Z-0981-03

A.R.C. Laser Photolysis Probe/Handpiece

Name: Z-0981-03 A.R.C. Laser Photolysis Probe/Handpiece
Creator: A.R.C. Laser Corp
Published: 2003-06-06
License: https://open.fda.gov/license/

A.R.C. Laser GmbH / initiated 2003-06-06 / Terminated / root cause: sterility

FDA source

A.R.C. Laser Corp began a recall of A.R.C. Laser Photolysis Probe/Handpiece on 2003-06-06. The reason FDA records is "Product may not have been properly sterilized". 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-0981-03
Status: Terminated
Initiated: 2003-06-06
Posted: 2003-07-03
Terminated: 2003-07-23
Recalling firm: A.R.C. Laser GmbH
Product: A.R.C. Laser Photolysis Probe/Handpiece
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Product may not have been properly sterilized.
Root cause tag: sterility
FDA root cause: Other
Action: The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.
Quantity in commerce: 370 units
Distribution: IN, NY, PA, TX.
Product codes and lots: Part Number: 1A55LM02 Catalog Number: LY11002

Product code GEX

K993154Class IILaser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. / cleared 2000-06-29

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)