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Hoya suspends sales of two clear-optic IOLs

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CHINO HILLS, Calif. — Hoya Surgical Optics has voluntarily suspended sales of two clear-optic IOLs in the United States and has requested that customers return them to the company, according to a press release from Hoya.

The action is limited to the iSymm IOL (model FC-60AD) and the iSert IOL (model PC-60AD), due to an issue with the approval status of clear-optic IOLs.

The company believes that the regulatory process will be more efficient if the lenses are returned while it works with the U.S. Food and Drug Administration, the release said.

"FDA has informed us they have not yet approved these lens models, and we have filed additional data as requested by them to obtain FDA approval," Steven L. Ziemba, vice president of global regulatory affairs at Hoya, said in the release.

The company has sent a letter to all affected customers with instructions on returning the lenses. Additional inquiries can be directed to Hoya customer service at 866-750-5870.