ClearanceBrief
Recall Z-0957-04 ยท KYB Lens, Guide, Intraocular

Staar Surgical Co Inc

MicroSTAAR Injector, MSI-PF Packed ten per box.

DateJul 20, 2004 (initiated Apr 21, 2004)
StatusTerminated
ReasonCracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
Root causeOther
ActionRecall will be implemented by visits by company representatives.
Quantity124 boxes, 10 per box.
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K980696FOAM TIP INJECTOR
Staar Surgical Co., Sep 11, 1998