ClearanceBrief
Recall Z-0775-05 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable

Staar Surgical Co Inc

STAAR Phaco Tubing Kit

DateApr 27, 2005 (initiated Mar 28, 2005)
StatusTerminated
ReasonComplaints of leaking with question of sterility and risk of infection in eye.
Root causeOther
ActionRecall was conducted by telephone and letter delivered by FEDEX on April 7, 2004. All consignees have been contacted.
Quantity114
DistributionCA, NV, UT, FL, OR.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.