Recall Z-0271-2016 ยท HQL Intraocular Lens
Alcon Research, Ltd.
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
| Date | Nov 25, 2015 (initiated Sep 29, 2015) |
| Status | Terminated |
| Reason | Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. |
| Root cause | Process design |
| Action | The firm, Alcon, sent an "FDA Notification-Update to Recall Z-2323-2015" letter, dated October 1, 2015, to its Consignee in Japan who have received AcrySof IQ Toric IOL models SN6AT6 to SN6AT9 in order to initiate the recovery of product. The letter described the product, problem and actions to be taken. The consignee was instructed to stop using these immediately and put on hold until sales representatives visit their site for withdrawal. Recall does not affect AcrySof IQ Monofocal IOLs or AcrySof IQ Toric IOL models SN6AT3, SN6AT4 and SN6AT5. |
| Quantity | 43,651 units |
| Distribution | International Only Distribution -- Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.