Carl Zeiss Ophthalmic Systems Inc Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
Brand
Carl Zeiss Ophthalmic Systems Inc
Lot Codes / Batch Numbers
serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935
Products Sold
serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935
Carl Zeiss Ophthalmic Systems Inc is recalling Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of d due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OR
Page updated: Jan 10, 2026