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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Carl Zeiss Meditec Inc
Lot Codes / Batch Numbers
User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
Products Sold
User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
Carl Zeiss Meditec Inc is recalling VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgic due to Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026