Z-0105-2012

OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a...

Name: Z-0105-2012 OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a...
Creator: Carl Zeiss Meditec, Inc.
Published: 2011-09-26
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2011-09-26 / Terminated / root cause: manufacturing process

FDA source

Carl Zeiss Meditec, Inc. began a recall of OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field on 2011-09-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0105-2012
Status: Terminated
Initiated: 2011-09-26
Posted: 2011-10-24
Terminated: 2011-11-04
Recalling firm: Carl Zeiss Meditec Inc
Product: OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.
Product code: EPT Microscope, Surgical
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 3
Distribution: USA (nationwide) including the states of FL, GA, and LA .
Product codes and lots: Serial numbers: 6636101067; 6636101068; 6636101070.

Product code EPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)