FDA Recall
Terminated
STAAR Surgical Intra Occular Lens, Collamer.
Recall: Z-1037-04
·
Initiated June 17, 2004
Recall
- Recall Number
- Z-1037-04
- Event Number
- 29384
- Firm
- Staar Surgical Co Inc
- FEI Number
- 2023826
- Product Code
- HQL
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 17, 2004
- Posted
- July 20, 2004
- Terminated
- January 4, 2005
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846
Description
STAAR Surgical Intra Occular Lens, Collamer.
Reason
Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
Action
Consignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
Distribution
Nationwide.
Quantity
Not specified.