ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular l
FDA device recall Z-2323-2015 · posted 2015-08-07 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
- Action taken
- 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
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 45,391
- Distribution
- Distribution Japan, No US distribution.
- Date initiated
- 2015-04-15
- Date posted
- 2015-08-07
- Date terminated
- 2017-06-30
- Location
- Fort Worth, TX
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