Z-0539-03

Conformer - Large with holes (Sterile)

Name: Z-0539-03 Conformer - Large with holes (Sterile)
Creator: Gulden Ophthalmics
Published: 2002-11-29
License: https://open.fda.gov/license/

Gulden Ophthalmics / initiated 2002-11-29 / Terminated / root cause: sterility

FDA source

Gulden Ophthalmics began a recall of Conformer - Large with holes (Sterile) on 2002-11-29. The reason FDA records is "lack of sterility assurance". 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-0539-03
Status: Terminated
Initiated: 2002-11-29
Posted: 2003-02-05
Terminated: 2004-02-06
Recalling firm: Gulden Ophthalmics
Product: Conformer - Large with holes (Sterile)
Product code: HQX Implant, Orbital, Extra-Ocular
Reason for recall: lack of sterility assurance
Root cause tag: sterility
FDA root cause: Other
Action: The recalling firm issued letters to the accounts requesting the return of the devices.
Distribution: Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Product codes and lots: model number 14169. lot number 1235

Product code HQX

K972661Class IIEye Sphere, ConformersGulden Ophthalmics / cleared 1997-10-03

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)