Novartis Unit Recalls AcrySof Intraocular Lenses in Japan

February 5, 2016

Novartis’ Alcon unit is recalling more than 43,000 units of its AcrySof IQ Toric, expanding a previous recall of more than 45,000 intraocular lenses earlier this year in Japan.

The Class 1 recall, which affects 43,651 units, was initiated following continued reports of postoperative inflammation in patients who received the device, according to an FDA recall notice.

Alcon sent an FDA notification letter Oct. 1 to its consignees in Japan who have received certain models, instructing them to stop using the products immediately and wait for a sales representative to visit their sites for withdrawal.

Alcon sent a similar letter April 16, 2015, regarding 45,391 of its AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses. That Class 1 recall followed reports of postoperative inflammation and toxic anterior segment syndrome after cataract surgery.

The FDA has determined that both recalls were caused by process design problems at Alcon in Fort Worth, Texas.

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