Events

Recall of OPMI VARIO 700 Surgical Microscope

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
    60017
  • Event Risk Class
    Class 2
  • Event Number
    Z-0105-2012
  • Event Date Posted
    2011-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104239
  • 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
    An incorrect nut and bolt set was used in the axis three (3) spring assembly of the opmi vario 700 surgical microscope distributed to three us locations.
  • Action
    Carl Zeiss Meditec had Field Service Engineers directly contact all affected customers. The Field Service Engineers will replace the defective component. Questions regarding this Field Corrective Action should be directed to the Director of Clinical/Regulatory Affairs at 925-557-4616.

Device

OPMI VARIO 700 Surgical Microscope
  • Model / Serial
    Serial numbers: 6636101067; 6636101068; 6636101070.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of FL, GA, and LA .
  • Product Description
    OPMI VARIO 700 Surgical Microscope. || Manufactured by: Carl Zeiss Meditec AG, || Oberkochen, Germany. || Provide a magnified view of the surgical field.
  • Manufacturer
    Carl Zeiss Meditec, Inc.

Manufacturer

Carl Zeiss Meditec, Inc.
  • Manufacturer Address
    Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin CA 94568-7562
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA