Alcon Laboratories in conjunction with Australian healthcare regulators issued a warning on certain intraocular lenses after receiving reports of higher-than-expected rates of accelerated endothelial cell loss.
Alcon warned that a 5-year study of its AcrySof Cachet Phakic Lenses uncovered that about 1 in 100 required removal as a result of ECL, with higher rates in patients with smaller eyes or who self-identified as being Asian.
The medical device maker already provides doctors with information on how to prevent ECL and only specially trained ophthalmologists who undergo yearly recertification may perform AcrySof Cachet Phakic Lenses procedures, but Alcon’s taking additional measures, according to a report from Australia’s Therapeutic Goods Administration.
Alcon issued a notice to all currently accredited ophthalmologists, recommending that they perform pre- and post-operative assessments and follow-up at 1 and 3 months after treatment, with 6-month follow-ups thereafter.
ECL in a condition marked by the loss of cells covering the surface of the cornea. The direct cause is unknown, but it is a known risk of implantation with a phakic lens, according to the TGA. There are no symptoms of the condition until it’s gotten bad enough to affect vision, regulators said.
