Company: Ellex, Inc.,
Date of Enforcement Report 1/2/2008
Class:ll
PRODUCT
Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Recall # Z-0148-2008
REASON
Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations. Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.
RECALLING FIRM/MANUFACTURER
Ellex, Inc., Sacramento, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
59 systems
DISTRIBUTION
Nationwide and Internationally
