Recall Z-0904-2011 ยท EPT Microscope, Surgical
Carl Zeiss Meditec Inc
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
| Date | Jan 14, 2011 (initiated May 18, 2009) |
| Status | Terminated |
| Reason | Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment. |
| Root cause | 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. Si |
| Quantity | 2540 units |
| Distribution | Worldwide Distribution including USA (nationwide) and the UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.