ClearanceBrief
Recall Z-0766-04 ยท KYB Lens, Guide, Intraocular

Staar Surgical Co Inc

MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

DateJul 20, 2004 (initiated Feb 23, 2004)
StatusTerminated
ReasonInjector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
Root causeOther
ActionFirm will be sending thier representatives to customers to inspect inventory and arrange return of product.
Quantity690 injectors
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.