Company:Carl Zeiss Meditec Inc.
Date of Enforcement Report 10/7/2009
Class:ll

PRODUCT
Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma. Recall # Z-2048-2009

REASON
Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS..

RECALLING FIRM/MANUFACTURER
Carl Zeiss Meditec Inc., Dublin, CA, by letter on July 2, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
244 units

DISTRIBUTION
Nationwide, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and Chinae