Z-0775-05

STAAR Phaco Tubing Kit

Name: Z-0775-05 STAAR Phaco Tubing Kit
Creator: Staar Surgical Co Inc
Published: 2005-03-28
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2005-03-28 / Terminated / root cause: sterility

FDA source

Staar Surgical Co Inc began a recall of STAAR Phaco Tubing Kit on 2005-03-28. The reason FDA records is "Complaints of leaking with question of sterility and risk of infection in eye". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0775-05
Status: Terminated
Initiated: 2005-03-28
Posted: 2005-04-27
Terminated: 2005-07-11
Recalling firm: Staar Surgical AG
Product: STAAR Phaco Tubing Kit
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: Complaints of leaking with question of sterility and risk of infection in eye.
Root cause tag: sterility
FDA root cause: Other
Action: Recall was conducted by telephone and letter delivered by FEDEX on April 7, 2004. All consignees have been contacted.
Quantity in commerce: 114
Distribution: CA, NV, UT, FL, OR.
Product codes and lots: Lot 08345

Product code GDY

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)