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