Events

Recall of Device Recall VISU 200

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Meditec 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
    52716
  • Event Risk Class
    Class 2
  • Event Number
    Z-0904-2011
  • Event Initiated Date
    2009-05-18
  • Event Date Posted
    2011-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83806
  • 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
    Microscope, surgical - Product Code EPT
  • Reason
    Potential retina damage-- an error in the user manual may result in misapplied filter and injury during treatment.
  • Action
    Carl Zeiss Meditec Inc sent a SAFETY ALERT letter dated May 18, 2009, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded to use the correct retinal protection filter (GG475) when using the OPMI VISU 200 system during ophthalmic surgery. Verify the position of the retinal protection filter and inform their staff of the customizable feature. Verify that the correct filter was in place. Customers were asked to complete the acknowledgement form indicating receipt of the alert. Sign and return the form to: Carl Zeiss Meditec in Dublin, California via the enclosed self-addressed, pre-paid Federal Express envelope. For any questions customers should call (925) 557-4422.

Device

Device Recall VISU 200
  • Model / Serial
    User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA (nationwide) and the UK
  • Product Description
    VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany || Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. || Product Quantity Distributed (Int) 2540 units
  • Manufacturer
    Carl Zeiss Meditec Inc

Manufacturer

Carl Zeiss Meditec Inc
  • Manufacturer Address
    Carl Zeiss Meditec Inc, 5160 Hacienda Dr, Dublin CA 94568
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA