HSO suspends clear-optic IOL sales

Chino Hills, CA-HOYA Surgical Optics, Inc. (HSO) announces that it has voluntarily suspended sales of two models of its clear-optic IOLs: the iSymm IOL (Model FC-60AD) and the iSert IOL (Model PC-60AD). This action affects only U.S. customers, and HSO has requested the return of these lenses.

HSO has been working with the FDA to resolve an issue regarding the approval status of the clear-optic lenses, and believes that the regulatory process will be more efficient if the lenses are returned while it continues to work with the FDA.

“[The] FDA has informed us [that] they have not yet approved these lens models, and we have filed additional data as requested by them to obtain FDA approval. While we are disappointed [that] this recall is required, we remain strongly committed to our U.S. customers and believe that our actions demonstrate our intent to work closely with them and the FDA to provide the same outstanding products and services that have allowed us to become the fastest-growing IOL company in the U.S.,” said Steven L. Ziemba, HSO’s vice president of global regulatory affairs.

For assistance, customers can call HSO toll-free, at 866/750-5870.