Z-0957-04

MicroSTAAR Injector, MSI-PF Packed ten per box

Name: Z-0957-04 MicroSTAAR Injector, MSI-PF Packed ten per box
Creator: Staar Surgical Co Inc
Published: 2004-04-21
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2004-04-21 / Terminated

FDA source

Staar Surgical Co Inc began a recall of MicroSTAAR Injector, MSI-PF Packed ten per box on 2004-04-21. The reason FDA records is "Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0957-04
Status: Terminated
Initiated: 2004-04-21
Posted: 2004-07-20
Terminated: 2012-07-26
Recalling firm: Staar Surgical AG
Product: MicroSTAAR Injector, MSI-PF Packed ten per box.
Product code: KYB Lens, Guide, Intraocular
Reason for recall: Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
FDA root cause: Other
Action: Recall will be implemented by visits by company representatives.
Quantity in commerce: 124 boxes, 10 per box.
Distribution: Nationwide
Product codes and lots: Lot 1186591 Expires 12/31/06 Lot 1186692 Expires 12/31/06

Product code KYB

K980696Class IFoam Tip InjectorStaar Surgical Co. / cleared 1998-09-11

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)