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Terminated

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

FDA Recall Z-1066-04 · Posted 2004-07-20

Recalling FirmCarl Zeiss Ophthalmic Systems Inc
Recall StatusTerminated
Product CodeGEX
Date Initiated2004-06-03
Date Terminated2005-01-11
Product Quantity20

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.

Firm Action

On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.

Root Cause

Other

Distribution Pattern

The product was distributed directly to health professionals or hospitals.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013402VISULAS 532SCarl Zeiss, Inc. · 2001-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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