Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric model
FDA device recall Z-0271-2016 · posted 2015-11-25 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 43,651 units
- Distribution
- International Only Distribution -- Japan.
- Date initiated
- 2015-09-29
- Date posted
- 2015-11-25
- Date terminated
- 2017-06-30
- Location
- Fort Worth, TX
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