AcrySof ReSTOR Intraocular Lens
FDA device recall Z-0430-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Alcon Laboratories, Inc
- Reason for recall
- Intraocular lenses exposed to extreme temperatures while in storage.
- Action taken
- The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- MFK
- Quantity affected
- 10 units
- Distribution
- Nationwide.
- Date initiated
- 2006-12-14
- Date posted
- 2007-02-15
- Date terminated
- 2008-04-09
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.