VISU 200 on S8 Floor Stand…

Date posted by the FDA

Jan. 14, 2011

Status

Terminated

Filed by

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

Reason

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

Distribution pattern

Worldwide Distribution including USA (nationwide) and the UK

Quantity

2540 units

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.

Recall started

May 18, 2009

Device type

Microscope, Surgical

Root cause (FDA)

Labeling mix-ups

What the company told customers

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.

Recall number

Z-0904-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0904-2011. The agency record governs; check it and the company before acting.