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U.S. Department of Health and Human Services

Class 2 Device Recall VISU 200

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  Class 2 Device Recall VISU 200 see related information
Date Initiated by Firm May 18, 2009
Date Posted January 14, 2011
Recall Status1 Terminated 3 on February 09, 2011
Recall Number Z-0904-2011
Recall Event ID 52716
Product Classification Microscope, surgical - Product Code EPT
Product 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
Code Information User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
Recalling Firm/
Manufacturer
Carl Zeiss Meditec Inc
5160 Hacienda Dr
Dublin CA 94568
For Additional Information Contact
925-557-4353 Ext. 4458
Manufacturer Reason
for Recall
Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.
FDA Determined
Cause 2
Labeling mix-ups
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.
Quantity in Commerce 2540 units
Distribution Worldwide Distribution including USA (nationwide) and the UK
Total Product Life Cycle TPLC 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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