Z-1037-04

STAAR Surgical Intra Occular Lens, Collamer

Name: Z-1037-04 STAAR Surgical Intra Occular Lens, Collamer
Creator: Staar Surgical Co Inc
Published: 2004-06-17
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2004-06-17 / Terminated / root cause: labeling and UDI

FDA source

Staar Surgical Co Inc began a recall of STAAR Surgical Intra Occular Lens, Collamer on 2004-06-17. The reason FDA records is "Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1037-04
Status: Terminated
Initiated: 2004-06-17
Posted: 2004-07-20
Terminated: 2005-01-04
Recalling firm: Staar Surgical AG
Product: STAAR Surgical Intra Occular Lens, Collamer.
Product code: HQL Intraocular Lens
Reason for recall: Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
Quantity in commerce: Not specified.
Distribution: Nationwide.
Product codes and lots: All lenses packaged weeks of 9-13 and 23-27 February.

Product code HQL

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)