Z-0766-04

MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

Name: Z-0766-04 MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Creator: Staar Surgical Co Inc
Published: 2004-02-23
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2004-02-23 / Terminated / root cause: manufacturing process

FDA source

Staar Surgical Co Inc began a recall of MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF on 2004-02-23. The reason FDA records is "Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0766-04
Status: Terminated
Initiated: 2004-02-23
Posted: 2004-07-20
Terminated: 2005-01-04
Recalling firm: Staar Surgical AG
Product: MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Product code: KYB Lens, Guide, Intraocular
Reason for recall: Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm will be sending thier representatives to customers to inspect inventory and arrange return of product.
Quantity in commerce: 690 injectors
Distribution: Nationwide.
Product codes and lots: Lot 11853090. Sterility Date : 11/18/2003 Expiration Date: 10/31/2006

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)