Z-0904-2011

VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical...

Name: Z-0904-2011 VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical...
Creator: Carl Zeiss Meditec Inc
Published: 2009-05-18
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2009-05-18 / Terminated / root cause: labeling and UDI

FDA source

Carl Zeiss Meditec Inc began a recall of VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical microscope used during ophthalmic surgeries, which... on 2009-05-18. The reason FDA records is "Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0904-2011
Status: Terminated
Initiated: 2009-05-18
Posted: 2011-01-14
Terminated: 2011-02-09
Recalling firm: Carl Zeiss Meditec Inc
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
Product code: EPT Microscope, Surgical
Reason for recall: Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.
Root cause tag: labeling and UDI
FDA 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. 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
Product codes and lots: User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.

Product code EPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)