Recall Z-2323-2015 ยท HQL Intraocular Lens
Alcon Research, Ltd.
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.
| Date | Aug 7, 2015 (initiated Apr 15, 2015) |
| Status | Terminated |
| Reason | There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery. |
| Root cause | Process design |
| 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. |
| Quantity | 45,391 |
| Distribution | Distribution Japan, No US distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.