Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

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.

↑