FDA Medical Device Recalls (openFDA)
Carl Zeiss Ophthalmic Systems Inc: Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
- Recall number
- Z-1066-04
- Recalling firm
- Carl Zeiss Ophthalmic Systems Inc
- Product
- Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
- Status
- Terminated
- Initiated
- 2004-06-03
- Posted
- 2004-07-20
- Terminated
- 2005-01-11
- Reason
- 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
- Other
- Action
- On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.
- Quantity
- 20
- Distribution
- The product was distributed directly to health professionals or hospitals.
- Lot, serial or model codes
- serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935
- 510(k) numbers
- ["K013402"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 2918630
- Firm city
- Dublin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28