Z-1066-04

Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases...

Name: Z-1066-04 Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases...
Creator: Carl Zeiss Ophthalmic Systems Inc
Published: 2004-06-03
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2004-06-03 / Terminated / root cause: manufacturing process

FDA source

Carl Zeiss Ophthalmic Systems Inc began a recall of Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye on 2004-06-03. The reason FDA records is "The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on...". 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-1066-04
Status: Terminated
Initiated: 2004-06-03
Posted: 2004-07-20
Terminated: 2005-01-11
Recalling firm: Carl Zeiss Meditec Inc
Product: Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal bleeding and burns may result.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.
Quantity in commerce: 20
Distribution: The product was distributed directly to health professionals or hospitals.
Product codes and lots: serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935

Product code GEX

K013402Class IIVisulas 532SCarl Zeiss, Inc. / cleared 2001-11-14

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)