Z-0228-04

Model LightLas 532 Opthalmic Photocoagulator Laser

Name: Z-0228-04 Model LightLas 532 Opthalmic Photocoagulator Laser
Creator: LightMed USA Inc
Published: 2003-11-11
License: https://open.fda.gov/license/

Light-Med (USA), Inc. / initiated 2003-11-11 / Terminated / root cause: manufacturing process

FDA source

LightMed USA Inc began a recall of Model LightLas 532 Opthalmic Photocoagulator Laser on 2003-11-11. The reason FDA records is "Firm needed to include calibration procedures in user guide". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0228-04
Status: Terminated
Initiated: 2003-11-11
Posted: 2003-12-17
Terminated: 2003-12-16
Recalling firm: Light-Med (USA), Inc.
Product: Model LightLas 532 Opthalmic Photocoagulator Laser
Product code: HQF Laser, Ophthalmic
Reason for recall: Firm needed to include calibration procedures in user guide.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.
Quantity in commerce: 2
Distribution: CA, GA
Product codes and lots: All codes

Product code HQF

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)