FDA Medical Device Recalls (openFDA)
Staar Surgical Co Inc: MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
- Recall number
- Z-0378-04
- Recalling firm
- Staar Surgical Co Inc
- Product
- MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
- Status
- Terminated
- Initiated
- 2004-01-06
- Posted
- 2004-01-29
- Terminated
- 2005-01-04
- Reason
- Increased numbers of lens tears during placement of lens into eye.
- Root cause
- Other
- Action
- Customers will recieve recall notice, Customer Bulletin and MicroStaar Injector Cartridge Guide by Federal Espress (sent 1/6/04).
- Quantity
- not on file
- Distribution
- Nationwide, Canada and Australia
- Lot, serial or model codes
- SFC-25 (8 lots) 1180608, 1181078, 1181170,1181171, 1181396, 1181397, 1182237, 1184864 MTC-60 (25 lots) 1177222, 1177950, 1178121, 1178212, 1176868, 1177421, 1178738, 1178883, 1178885, 1179023, 1181789, 1181790, 1181797, 1181798, 1181980, 1182245, 1182342, 1182343, 1182344, 1182345, 1182675, 1182676, 1182677, 1182761.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYB
- Firm FEI
- 2023826
- Firm city
- Monrovia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28