Events

Recall of Device Recall Visulas 532 s with Visulink 532/U

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Ophthalmic Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29367
  • Event Risk Class
    Class 1
  • Event Number
    Z-1066-04
  • Event Initiated Date
    2004-06-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33608
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered Laser Surgical Instrument - Product Code GEX
  • 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.
  • Action
    On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.

Device

Device Recall Visulas 532 s with Visulink 532/U
  • Model / Serial
    serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed directly to health professionals or hospitals.
  • Product Description
    Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
  • Manufacturer
    Carl Zeiss Ophthalmic Systems Inc

Manufacturer

Carl Zeiss Ophthalmic Systems Inc
  • Manufacturer Address
    Carl Zeiss Ophthalmic Systems Inc, 5160 Hacienda Dr, Dublin CA 94568-7562
  • Source
    USFDA