FDA Recall
Terminated
MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
Recall: Z-0378-04
·
Initiated January 6, 2004
Recall
- Recall Number
- Z-0378-04
- Event Number
- 28070
- Firm
- Staar Surgical Co Inc
- FEI Number
- 2023826
- Product Code
- KYB
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 6, 2004
- Posted
- January 29, 2004
- Terminated
- January 4, 2005
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846
Description
MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
Reason
Increased numbers of lens tears during placement of lens into eye.
Action
Customers will recieve recall notice, Customer Bulletin and MicroStaar Injector Cartridge Guide by Federal Espress (sent 1/6/04).
Distribution
Nationwide, Canada and Australia