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Terminated

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

FDA Recall Z-0904-2011 · Posted 2011-01-14

Recalling FirmCarl Zeiss Meditec Inc
Recall StatusTerminated
Product CodeEPT
Date Initiated2009-05-18
Date Terminated2011-02-09
Product Quantity2540 units

Reason for Recall

Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution including USA (nationwide) and the UK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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