Company:Clarity Medical Systems Inc.
Date of Enforcement Report 3/21/12
Class ll:

PRODUCT
Retcam3 & Retcam Shuttle with version 6.0 software. General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. Model number RC3, part number 21-100500; Model number RCS, part number 20-000300. Recall # Z-1099-2012

REASON
Still images extracted from video recordings may be mislabeled as to right and left eye.

RECALLING FIRM/MANUFACTURER
Clarity Medical Systems Inc., Pleasanton, CA, by letter dated February 7, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 RetCam Shuttles and 20 RetCam3

DISTRIBUTION
Nationwide and Internationally