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

FDA device recall Z-0904-2011 · posted 2011-01-14 · Terminated

Recall details

Recalling firm

Carl Zeiss Meditec Inc

Reason for recall

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

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

EPT

Quantity affected

2540 units

Distribution

Worldwide Distribution including USA (nationwide) and the UK

Date initiated

2009-05-18

Date posted

2011-01-14

Date terminated

2011-02-09

Location

Dublin, CA