|24 September 2014||AcrySof Cachet phakic lens - update|
Health professionals and consumers are advised that Alcon Laboratories Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet Phakic Lenses.
AcrySof Cachet Phakic Lenses are implanted in the eye to treat nearsightedness (myopia) in adults aged 21 years or older.
Review of a five-year global study into the safety and efficacy of AcrySof Cachet Phakic Lenses has revealed that a small number of implanted lenses (about 1%) have been removed as a result of accelerated endothelial cell loss (ECL). Analyses have indicated a trend for higher rates of ECL in.
- patients with smaller eyes
- patients who self-identified as being Asian.
Only specially-trained ophthalmologists, who undertake yearly training and recertification, are accredited to implant AcrySof Cachet Phakic Lenses and information to reduce the risk of ECL is already included in the directions for use (DFU). However, as a precautionary measure, Alcon Laboratories Australia Pty Ltd is implementing additional risk mitigation strategies
Information for consumers
The cause of endothelial cell loss (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 crucial that you undertake assessment by your ophthalmologist every six months (or more frequently if your ophthalmologist considers it necessary). Patients with a newly-implanted lens should be assessed one month and again three months after implantation, before establishing the six-monthly monitoring schedule.
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 all 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, if possible, be referred to the implanting ophthalmologist.
Information for ophthalmologists
Alcon Laboratories Australia is writing to all ophthalmologists currently accredited to implant AcrySof Cachet Phakic Lenses, advising of findings of the global study and new risk mitigation strategies.
Ophthalmologists should now follow the recommended pre-operative assessment and post-operative follow-up schedule for ECD assessment at one month, three months and six months, and thereafter at six-month intervals, including for already implanted patients.
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 already implanted, ophthalmologists are advised to discuss with patients the need for strict compliance with the monitoring requirements outlined in the DFU. 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.
Consumers and health professionals are encouraged to report problems with medical devices. 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.