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General
Times news report and the Alcon LADARVision®
United Kingdom FAQ
Implications for patient safety
Patients who have had surgery and think they may have been injured
Consumers who are considering getting laser eye surgery
United States consumer/patient FAQ
Implications for patient safety
Patients who have had surgery and think they may have been injured
Consumers who are considering getting laser eye surgery
General
FAQ about the Alcon LADARVision® and the Times news report
Q: What is the Alcon LADARVision®?
A: The Alcon LADARVision® is an excimer laser originally developed by Autonomous Technologies. Autonomous was acquired by Summit in 1999 and renamed Summit Autonomous, then acquired by Alcon (the laser's current owner) in 2000. The Alcon LADARVision® currently enjoys FDA approval for a wider range of correction types and amounts than any other excimer laser in the US.
Alcon is one of many excimer laser manufacturers. Others include VISX (the market leader), Bausch & Lomb, Nidek, Carl Zeiss Meditec, and Wavelight. According to MarketScope's November 2003 report, approximately 32% of excimer lasers sold in the US in 2003 were LADARVision® lasers; internationally approximately 13% were LADARVision® lasers.
Q: What sorts of problems have been reported by the Times? How serious are they?
A: The Times report discusses allegations of device faults leading to (a) high rates of retreatment (i.e. requirement for second surgeries) and (b) damage to eyesight caused by many of the Alcon LADARVision lasers. The Times report cites sources including certain lawsuits filed in the US against Alcon, documents obtained by the Times, and information from some surgeons who have used the devices.
Q: What is Alcon's response to the report?
A: Alcon issued a statement entitled “Alcon Statement Re: The Times of London Article of August 28, 2004” in which they charaterised the allegations as “false and innacurate”. We recommend readers look up the statement on a search engine and read it.
Q: How many lasers could be affected if these reports are true?
A: The Times say they have information from more than 20 doctors in Canada and the US but they report only that some, rather than all, lasers are affected. According to MarketScope's November 2003 comprehensive report on the refractive market, approximately 10% of the installed base of lasers worldwide in 2003 were Alcon LADARVision® lasers, specifically, 445 units, 320 of which were in the US and 125 outside the US. So, the allegations apparently apply to an unknown number of those 445 lasers.
Q: How long are the alleged problems said to have been occurring?
A: The Times reported that leaked Alcon data indicate erratic problems occurring betwen 2000 and 2002.
Q: Are there implications for any other types of lasers? Could similar allegations be laid at the door of other manufacturers?
A: We hope that laser manufacturers and laser clinics will promptly give the public the assurance it needs that no other problems exist on this scale by adopting an "open book" policy for their results and by developing better tracking mechanisms for long-term use.
LaserMyEye position
Q: What is LaserMyEye?
A: LaserMyEye is a patient advocacy group run by patients with complications from laser eye surgeries. Its mission is to make laser eye surgery safer and to assist patients who are unfortunate enough to experience complications. For further background on LaserMyEye, please see the About page and the Press Corner page of this website.
Q: How concerned is LaserMyEye about the report in the Times?
A: The nature and magnitude of the allegations make it impossible for us not to be concerned. On a broader level, we have long been concerned about the absence of regulations to track outcomes and complications rates from laser eye surgery and we have been campaigning for such regulations to be implemented.
Q: What does LaserMyEye want to see happen in the short-term?
A: Patients need to have confidence about what they are dealing with. We believe that Alcon should take the following steps to reassure doctors and patients, since they alone have all the information available to them: 1) Alcon asserted in their press release that the Times was relying on invalid retreatment data. Therefore it seems reasonable to expect that Alcon would hasten to make valid retreatment data available in equivalent detail to disprove the allegations. 2) Alcon asserted that the allegations in the Times were voiced by parties in debt to or in financial disputes with Alcon. Yet the Times referred to “more than 20” surgeons. Alcon should reveal how many complaints they have received from surgeons about suspected device malfunctions and what the status of those complaints are.
If such basic questions as those cannot be answered satisfactorily, we feel the LADARVision® laser should be voluntarily withdrawn from service by doctors until the reports have been fully investigated, so as to ensure the safety and welfare of patients. As patient advocates we cannot in good conscience fail to alert patients to this report until we receive conclusive evidence that it is false.Q: What does LaserMyEye want to see happen in the long-term?
A: The recent reports, whether true or not, highlight the risk inherent in failing to proactively monitor trends in laser eye surgery outcomes.
We therefore want to see the introduction of voluntary or mandatory schemes whereby clinics and surgeons track, make available to patients, and report to a regulatory body their laser eye surgery results (including retreatment rates, complications and adverse effects). Availability of this data to patients at the clinic they have chosen would permit them to make a properly informed decision about surgery. Collation of this data on a regional and national level would permit adverse trends to be identified early on.
Q: What is LaserMyEye prepared to do to assist?
A: LaserMyEye is calling on laser clinics everywhere, regardless of which laser platform they employ, to work cooperatively with us to devise standardised patient assessment forms including both objective test results and subjective patient feedback. We believe that this will not only enhance safety standards in laser eye surgery but also provide a valuable means of assessing patient satisfaction.
Q: Does LaserMyEye recommend laser vision correction procedures?
A: We recognise that laser eye surgery is desirable to many people and that since many people will get it done, we want to help ensure they get it done as safely as possible. This is why patient education, patient screening, informed consent and doctor qualifications are also high on our agenda.
Q: Do the reports about the Alcon LADARVision® mean that laser surgery is dangerous and people should refrain from having it done?
A: There is no need for panic. Nothing about laser surgery has changed overnight. The information emerging about the Alcon LADARVision® has simply underscored the need for tracking and reporting of results, complications and adverse effects, which LaserMyEye has long campaigned for. The old adage “Trust, but verify” comes readily to mind. Now, as before, we strongly encourage all prospective patients to:
- Seek an expert surgeon with specialised training.
- Request statistics of results, complications and adverse effects for the clinic/surgeon.
- Carefully research and assess any risk factors individual to the patient which may predispose him/her to a poorer outcome.
- Refer to the LaserMyEye.org website for further assistance. The Consumer Guide to laser eye surgery will be published on this website in September 2004. Click here to be notified when it is published.
United Kingdom FAQ
FAQ re implications for patient safety
Q: Does the Times report apply to the United Kingdom?
A: Only about 10% of lasers installed in the UK are Alcon LADARVision® lasers, the type reported on by the Times. Of those, we do not know for certain whether any have been affected and if so in what degree. We will have to wait for further information, statements by the applicable clinics and investigation by the MHRA. But we are clearly talking about a minority of lasers used in the UK.
Q: What problems did the Times report discuss?
A: The Times report discusses erratic laser performance resulting in blurred vision or in some cases damaged eyesight.
Q: Which clinics use the Alcon laser in the UK?
A: About 10% of clinics in the UK use the Alcon LADARVision®. According to our information these are Boots Laser Eye Clinics (which has nine laser eye centres throughout the UK – eight in England and one in Scotland) and Kirkwood Fyfe in Aberdeen. On 14 September 2004 Boots plc announced that it was shutting down the laser clinics as part of a broader move to reduce unprofitable healthcare services.
Other types of lasers used in the UK include the Bausch & Lomb Technolas 217, the Nidek EC4000, the VISX Star S4, the Wavelight Allegretto, the Carl Zeiss Meditec Mel-80.
Q: What response have Boots made to the Times?
A: Boots denied that there was a problem with any of its lasers and stated that in 2003 8% of patients required retreatments and the vast majority achieved driving standard vision with one operation. Boots declared that they were contacting 49 patients treated on a laser in the Regent Street clinic prior to a corrective action taken by Alcon although they said the company was certain that no errors had occurred with that single suspect machine, which had always had good retreatment rates.
UPDATE: Boots plc announced on 14 September that they are shutting down their laser clinics as part of a broader reduction in healthcare services which were not producing profits.
Q: Has the appropriate UK authority certified the LADARVision® lasers for in use in the UK?
A: All excimer lasers and their manufacturers are subject to stringent regulatory control to ensure they pass the necessary standards for health and safety. The Alcon LADARVision® will have been certified for use by the Medicines and Healthcare Products Regulatory Agency (MHRA). The Alcon LADARVision® has also received regulatory approvals from authorities in the US, throughout Europe and in many other countries around the world.
Q: What safeguards are there to prevent this kind of thing happening in Britain?
A: There are a number of regulatory authorities in the UK that monitor and assess the safety of medical technology and its application. These agencies include the Healthcare Commission, the Optical Surveillance Unit (part of the Royal College of Ophthalmologists) and The Medical Devices Agency (part of the MHRA). However, historically, reporting of adverse events is down to individual clinics, surgeons and patients.
Q: Why was a Parliamentary Panel of Enquiry set up to look into the safety of eye laser surgery in the UK?
A. In the past five years laser eye correction has become increasingly popular as a form of elective surgery and in fact is believed to be the most frequently performed form of elective surgery ever. As the market has expanded, the need for more formal regulation has become apparent and necessary. The Panel of Enquiry is a voluntary body of concerned MPs who set out to look at aspects of the current system which may need to be altered or augmented in line with today's needs.
Q: What were the specific areas that the Panel chose to investigate and what are their findings? Do they believe there are reasons to be concerned for patient safety?
A: The Panel has spent several months exploring and investigating the industry and whether sufficient checks and balances are in place.
The Panel has identified several areas of concern that it will outline in a formal Report to the Royal College of Ophthalmologists and the Department of Health later this year. The Panel's primary focus is in the area of surgeon accreditation and training; accurate and balanced patient information outlining the risks as well as the benefits of surgery; ensuring responsible advertising and promotion; and the setting up of a robust framework for monitoring and ensuring that these standards are properly applied.
Q: Will this crisis hurt consumer confidence in laser vision correction?
A: Most consumers will understand that this report relates to one kind of laser only, and one that is not widely used in the UK, and furthermore that we have not yet seen specific evidence that there are problems in the UK of the type reported by the Times. At the same time however the public may understandably raise questions as to how situation described by the Times could have continued undetected on an international level as long as it reportedly has done and whether UK has sufficient regulatory controls to prevent this happening here.
At LaserMyEye we feel that all clinics should track statistics on their results, complications and adverse effects and should operate an “open book” with those statistics, making them available to patients who are considering surgery and to regulatory authorities for trend monitoring. Such an approach could do much to assuage concerns.
FAQ for patients who have had surgery and think they may have been injured
Q: I had laser surgery but I don't know what kind of laser was used. How can I be sure?
A: Telephone the clinic where you had surgery, tell them the date of your surgery and ask them what brand of laser was used. However, if your surgery was performed in the UK, it was almost certainly not the Alcon LADARVision® unless it was done at Boots, Kirkwood Fyfe or the Rosen Eye Surgery Centre.
Q: I had surgery on the Alcon LADARVision® and I believe I may have been injured by the surgery. Where should I take my concerns?
A: Any individual who is concerned about their personal outcome following laser vision correction should return to their Clinic and ask that their condition is reviewed by a qualified surgeon who is experienced and expert in laser eye surgery. Be sure to request a copy of all exams performed or notes taken during your appointment.
You may also choose to alert the Adverse Incident Centre, which is part of the Medicines and Healthcare Products Regulatory Agency. The adverse Incident Centre deals with issues relating to a medical device or technology. The number to contact is 0207 972 8187.
If your concern relates to the clinic or surgical competence then you should contact the Healthcare Commission.
Numbers to contact are:
Beverley Cole: 0207 448 9019
Dawn Harwood: 077898 760 60
Q: I recently underwent laser vision correction with Boots and although I was pleased overall, I still suffer some residual problems. I haven't bothered to follow-up because they are relatively minor. Till now I was prepared to accept and manage these minor problems. But now I think they may have been caused specifically by the Alcon laser. What should I do?
A: Return to the clinic where you had surgery and insist on being seen and have your condition reviewed by a qualified surgeon who is expert and experienced in laser vision correction. Preferably the surgeon who operated on you originally. Be sure the request a copy of all exams performed or notes taken during your appointment.
If you don't receive a satisfactory review and response and/or choose to pursue the matter further, you may choose to alert the Adverse Incident Centre that is part of the Medicines and Healthcare Products Regulatory Agency. The number to contact is 0207 972 8187.
Any clinic that receives a complaint is obliged to notify the MHRA. However, you may wish to undertake this course of action regardless.
FAQ for consumers who are considering getting laser eye surgery
Q: Is laser vision correction safe? Should I still be considering surgery?
A: The report by the Times only discusses problems specific to the Alcon LADARVision® laser platform - not the overall safety of laser refractive procedures.
LaserMyEye cannot tell a consumer whether they should or should not get laser eye surgery as that is up to the individual, his medical and ocular conditions, his needs, requirements and expectations, and his tolerance for risk. We strongly recommend that all people considering getting laser eye surgery take the following steps as a minimum:
- Find an expert and experienced surgeon who has specialised in refractive eye surgery.
- Ask to see your surgeon's outcome statistics; make sure they are current, apply to only the surgeon's patients, and are for patients done on the laser that will be used for your surgery. These statistics should include, as a minimum, what percentage of patients: (a) achieved 20/20 without glasses in a first surgery; (b) required a second surgery; (c) saw worse afterwards even with glasses; (d) had complications (make sure the types of complications included are specified); (e) had poorer night vision; and (f) had persistent dry eye.
- Clarify your personal ‘risk' equation based on your prescription, any pre-existing conditions, general health and so on. Pay particular attention to any risk factors for night vision problems or persistent dry eye.
- Discuss with your surgeon in detail your needs and expectations from laser eye surgery.
- Visit LaserMyEye.org for further information. In October 2004, LaserMyEye will be launching the Consumer Guide to Laser Eye Surgery on this website. Click here if you wish to be notified when this is published.
Q: Should I wait to have surgery till after the Panel of Enquiry recommendations have been fully implemented?
A: The Panel of Enquiry Report is likely to put forward some very sensible and practical elements which will certainly bring a new level of security and confidence to anyone contemplating surgery. This does not necessarily mean that patients who have properly considered the suitability of laser eye surgery for them and have identified the best doctor to meet their needs need to delay, so long as they feel fully apprised of all the information they need to make a prudent decision.
Q: Can you recommend an expert and qualified laser eye surgeon in the UK?
A: LaserMyEye does not review the performance of laser eye surgeons in the UK and therefore cannot make recommendations. Excellent surgeons may be found in a variety of settings. Reviewing a surgeon's qualifications and experience, and asking for a set of detailed information about the surgeon's results (including vision results, retreatment rates, complications rates and rates of adverse effects) may help patients identify the best surgeons.
United States consumer/patient FAQ
FAQ re implications for patient safety
Q: What are the implications of the Times report for patients in the US?
A: We do not know the specific extent of the alleged problems; this could only be determined by a thorough investigation of the surgical outcomes at each individual clinic using the Alcon LADARVision® and by Alcon themselves volunteering more information about retreatments and complaints from surgeons. The Times say they have information from more than 20 doctors in Canada and the US; a leaked Alcon data report on retreatment rates, which the Times cites, suggests a more widespread problem.
Q: What problems did the Times report discuss?
A: The Times report discusses erratic laser performance resulting in blurred vision or in some cases damaged eyesight.
Q: Which clinics use the Alcon LADARVision® laser? How widespread is its use in the US?
A: According to MarketScope there are 320 Alcon LADARVision® lasers installed in the US. To determine whether a specific clinic uses the Alcon LADARVision®, see the LADARVision website.
Q: Is the Alcon LADARVision® FDA approved?
A: Yes. It was approved in 1998 for PRK, in 2000 for LASIK, and in 2002 for CustomCornea (Wavefront-guided laser ablations). It is believed to have the widest range of treatment parameters approved by the FDA for any excimer laser.
Q: Are the FDA looking into the matter? What are they doing about it?
A: The Times say that an FDA spokesman declined to say whether it was investigating the safety of Ladarvision devices. He said that the agency knew of allegations against Alcon but was "not aware" that Alcon has reported any increase in retreatment rates.
Q: What safeguards are in place to prevent this kind of thing happening?
A: The FDA is the primary regulatory authority in the US to monitor and assess the safety of medical devices All ophthalmic devices such as excimer lasers are required to obtain approval from the FDA before they can be marketed and operated commercially. This is a rigorous and lengthy process and can take up to three years.
Once the device is in the market, the manufacturer is required to inform the FDA of any changes to the device and may be required to file for approval for critical changes. Furthermore, the manufacturer has specific obligations to report back to the FDA if, for example, there is an increase of adverse events associated with the device or an increased incidence of known adverse events that had been reported during clinical trials.
FAQ for patients who think they may have been injured
Q: I had laser surgery but I don't know what kind of laser was used. How can I be sure?
A: Telephone the clinic where you had surgery, tell them the date of your surgery and ask them what brand of laser was used. If they have (or had) more than one kind of laser, ask them to check your medical records there to be certain which laser was used.
Q: I had surgery on the Alcon LADARVision® and I believe I may have been injured by the surgery. What should I do?
A: Any individual who is concerned about their personal outcome following laser vision correction should return to their clinic and ask that their condition is reviewed by a qualified surgeon who is experienced and expert in laser eye surgery. If the clinic is no longer in business, seek another qualified expert for a thorough review. Be sure to request a copy of all exams performed or notes taken during your appointment.
Q: I had surgery on the Alcon LADARVision® and I am convinced I have been injured by the surgery. Where can I report this?
A: We strongly encourage you to undergo a thorough examination before reporting your problem. You may alert the FDA by filing a report via the MedWatch programme (click here for details). It is preferable for this to be done with the assistance of your surgeon, who can provide important clinical data, but it can also be done by any patient via the online submission form.
In addition to government agencies there are also professional bodies (notably the American Society of Cataract and Refractive Surgeons - click here for their website) and non-profit organisations (such as Medical Device Safety Reports - click here for details) that you may wish to contact.
If your concern relates also to medical or clinical competence, you should contact your state medical board. You can find their website addresses by clicking here for the Federation of State Medical Boards website.
Q: I recently underwent laser vision correction with the Alcon LADARVision® and although I was initially pleased, I still suffer some residual problems. I haven't bothered to follow-up because they are relatively minor. Till now I was prepared to accept and manage these minor problems. But after reading the press reports describing the problems others have encountered, I think they may have been caused specifically by the Alcon laser. What should I do?
A: Return to the clinic where you had surgery and ask to be seen and have your condition reviewed by a qualified surgeon who is expert and experienced in laser vision correction. Be sure to request a copy of all exams performed or notes taken during your appointment.
If you don't receive a satisfactory review and response and/or choose to pursue the matter further, you may choose to take further action (see above).
FAQ for consumers who are considering getting laser eye surgery
Q: Is laser vision correction safe? Should I still be considering surgery?
A: The report by the Times only discusses alleged problems specific to one type of laser, not the overall safety of laser refractive surgery.
LaserMyEye cannot tell a consumer whether they should or should not get laser eye surgery as that is up to the individual, his medical and ocular conditions, his needs, requirements and expectations, and his tolerance for risk. We strongly recommend that all people considering getting laser eye surgery take the following steps as a minimum:
- Find an expert and experienced surgeon who has specialised in refractive eye surgery.
- Ask to see your surgeon's outcome statistics; make sure they are current, apply to only the surgeon's patients, and are for patients done on the laser that will be used for your surgery. These statistics should include, as a minimum, what percentage of patients: (a) achieved 20/20 without glasses in a first surgery; (b) required a second surgery; (c) saw worse afterwards even with glasses; (d) had complications (make sure the types of complications included are specified); (e) had poorer night vision; and (f) had persistent dry eye.
- Clarify your personal ‘risk' equation based on your prescription, any pre-existing conditions, general health and so on. Pay particular attention to any risk factors for night vision problems or persistent dry eye.
- Discuss with your surgeon in detail your needs and expectations from laser eye surgery.
- Visit LaserMyEye.org for further information. In October 2004, LaserMyEye will be launching the Consumer Guide to Laser Eye Surgery on this website. Click here if you wish to be notified when this is published.
Q: Can you recommend an expert and qualified laser eye surgeon in the US?
A: LaserMyEye does not review the performance of laser eye surgeons in the US and therefore cannot make recommendations. Excellent surgeons may be found in a variety of settings. Reviewing a surgeon's qualifications and experience, and asking for a set of detailed information about the surgeon's results (including vision results, retreatment rates, complications rates and rates of adverse effects) may help patients identify the best surgeons.
