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U.S. Department of Health and Human Services

Class 2 Device Recall OPMI VARIO 700 Surgical Microscope

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 Class 2 Device Recall OPMI VARIO 700 Surgical Microscopesee related information
Date Initiated by FirmSeptember 26, 2011
Date PostedOctober 24, 2011
Recall Status1 Terminated 3 on November 04, 2011
Recall NumberZ-0105-2012
Recall Event ID 60017
Product Classification Microscope, surgical - Product Code EPT
ProductOPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.
Code Information Serial numbers: 6636101067; 6636101068; 6636101070.
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information ContactJudith A. Brincombe, M.A.
925-557-4616
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCarl 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 Commerce3
DistributionUSA (nationwide) including the states of FL, GA, and LA .
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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