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
- Company
- Carl Zeiss Meditec Inc
- Recall Initiated
- May 18, 2009
- Posted
- January 14, 2011
- Terminated
- February 9, 2011
- Recall Number
- Z-0904-2011
- Quantity
- 2540 units
- Firm Location
- Dublin, CA
Reason for Recall
Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.
Distribution
Worldwide Distribution including USA (nationwide) and the UK
Lot / Code Info
User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
Root Cause
Labeling mix-ups
Action Taken
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.