Consumers and health professionals are advised that Alcon Laboratories Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet phakic lenses and has withdrawn the lenses from the market. This statement updates a previous safety alert, which the TGA published on 10 April 2013.
AcrySof Cachet phakic lenses are implanted in the eye to treat moderate to severe nearsightedness (myopia) in adults aged 21 years or older.
Data analysis from an ongoing 10-year global study into the safety and performance of AcrySof Cachet phakic lenses indicated an increase in the number of cases of endothelial cell loss (ECL) among implanted patients, with about 2.7% of implants being removed for this reason.
This hazard alert does not apply to other intraocular lenses in the AcrySof range.
Information for consumers
The cause of ECL is not well understood and there are no symptoms of the condition until endothelial cell density (ECD) is low enough to negatively affect your vision.
For these reasons, if you have an AcrySof Cachet phakic lens, it is important that you follow your ophthalmologist’s instructions, including undertaking assessment by your ophthalmologist every six months (or more frequently if your ophthalmologist considers it necessary).
If evidence of significant ECL is identified, your ophthalmologist may decide it is necessary to remove the lens.
If you have any general questions or concerns about phakic lenses, contact your ophthalmologist.
Information for health professionals
Patients with any questions or concerns about phakic lenses should be referred to an ophthalmologist.
Patients who have a phakic lens implanted and are experiencing any problems with their vision should be referred to the implanting ophthalmologist.
Information for ophthalmologists
Alcon Laboratories Australia is writing to all ophthalmologists who have implanted AcrySof Cachet phakic lenses, advising of the findings of the global study and the withdrawal of the lenses from the market.
Ophthalmologists should now follow the recommended post-operative follow-up schedule for ECD assessment at one month, three months and six months, and thereafter at six-month intervals.
If ECL is observed at greater than a 30% (when compared to the pre-operative cell count) and/or count below 1500 cells/mm2, the need for explantation should be considered and discussed with the patient. Any ECL at levels such as described above and/or any lens explantation must be reported to the TGA.
For patients with AcrySof Cachet Phakic Lenses implanted, ophthalmologists are advised to discuss with patients the need for strict compliance with the monitoring requirements outlined in the Directions for Use. Strict adherence to these requirements by patients will help with the timely identification of ECL and help in the determination of an appropriate treatment plan.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.