ClearanceBrief
Recall Z-0378-04 ยท KYB Lens, Guide, Intraocular

Staar Surgical Co Inc

MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)

DateJan 29, 2004 (initiated Jan 6, 2004)
StatusTerminated
ReasonIncreased numbers of lens tears during placement of lens into eye.
Root causeOther
ActionCustomers will recieve recall notice, Customer Bulletin and MicroStaar Injector Cartridge Guide by Federal Espress (sent 1/6/04).
DistributionNationwide, Canada and Australia
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.