Voluntary Recall of Clear IOL in the US

Hoya Surgical Optics, Inc. (a wholly owned subsidiary of Hoya Corporation) which distributes Hoya’s IOL (intraocular lens) in the US, announced the suspension of sales and the removal of clear-optic IOLs (Model FC-60AD, Model PC-60AD) from the US market, including field inventory. This is required because the FDA has informed HSO that they have not yet approved these lens models.

This voluntary action is required only in the US. It does not affect approvals or sales in other countries and HSO will continue sales of these lenses in Japan, Europe and Asia/Oceania. HSO continues to work on resolving this with the FDA and once the FDA approval is issued, HSO will start selling these products again in the US.