Z-0378-04

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

Name: Z-0378-04 MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized...
Creator: Staar Surgical Co Inc
Published: 2004-01-06
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2004-01-06 / Terminated

FDA source

Staar Surgical Co Inc began a recall of MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens) on 2004-01-06. The reason FDA records is "Increased numbers of lens tears during placement of lens into eye". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0378-04
Status: Terminated
Initiated: 2004-01-06
Posted: 2004-01-29
Terminated: 2005-01-04
Recalling firm: Staar Surgical AG
Product: MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
Product code: KYB Lens, Guide, Intraocular
Reason for recall: Increased numbers of lens tears during placement of lens into eye.
FDA root cause: Other
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
Product codes and lots: 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.

Product code KYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)