OPMI VARIO 700 Surgical Microscope…

Date posted by the FDA

Oct. 24, 2011

Status

Terminated

Filed by

Carl Zeiss Meditec, Inc.

Product

OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

Reason

An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations.

Distribution pattern

USA (nationwide) including the states of FL, GA, and LA .

Quantity

3

Codes and lots

Serial numbers: 6636101067; 6636101068; 6636101070.

Recall started

Sept. 26, 2011

Device type

Microscope, Surgical

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Carl Zeiss Meditec had Field Service Engineers directly contact all affected customers. The Field Service Engineers will replace the defective component. Questions regarding this Field Corrective Action should be directed to the Director of Clinical/Regulatory Affairs at 925-557-4616.

Recall number

Z-0105-2012

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

Source: FDA · Medical device enforcement report, recall number Z-0105-2012. The agency record governs; check it and the company before acting.