Z-0539-04

Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF

Name: Z-0539-04 Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
Creator: Staar Surgical Co Inc
Published: 2004-02-09
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2004-02-09 / Terminated

FDA source

Staar Surgical Co Inc began a recall of Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF on 2004-02-09. The reason FDA records is "Risk of hyperopic refractive changes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0539-04
Status: Terminated
Initiated: 2004-02-09
Posted: 2004-02-18
Terminated: 2005-01-04
Recalling firm: Staar Surgical AG
Product: Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
Product code: HQL Intraocular Lens
Reason for recall: Risk of hyperopic refractive changes.
FDA root cause: Other
Action: Firm is distributing letters to physicians suggesting ways to mitigate the observed contracture of the eye tissues after implantation. Letters will be sent 2/9/2004.
Quantity in commerce: No quantity applies.
Distribution: Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.
Product codes and lots: No codes apply

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)