ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
FDA Recall Z-2323-2015 · Posted 2015-08-07
Advertisement
Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHQL
Date Initiated2015-04-15
Date Terminated2017-06-30
Product Quantity45,391
Reason for Recall
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Firm Action
Alcon Research sent recall notification letters dated April 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product and place on hold until their sales representatives visit their site for withdrawal. Follow up communication activities included personal contact via phone and site visits. For questions regarding this recall call 817-293-0450.
Root Cause
Process design
Distribution Pattern
Distribution Japan, No US distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement