STAAR Surgical Intra Occular Lens, Collamer.
FDA device recall Z-1037-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Staar Surgical Co Inc
- Reason for recall
- Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
- Action taken
- Consignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- Not specified.
- Distribution
- Nationwide.
- Date initiated
- 2004-06-17
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-04
- Location
- Monrovia, CA
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