ClearanceBrief
Recall Z-1037-04 ยท HQL Intraocular Lens

Staar Surgical Co Inc

STAAR Surgical Intra Occular Lens, Collamer.

DateJul 20, 2004 (initiated Jun 17, 2004)
StatusTerminated
ReasonMislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
Root causeOther
ActionConsignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
QuantityNot specified.
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.