Company: Haag-Streit USA Inc.
Date of Enforcement Report 9/14/11
Class ll:

PRODUCT
Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal. Part Number 7220162. Recall # Z-2964-2011

REASON
A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Haag-Streit USA Inc., Mason, OH, by letter dated June 20, 2011.
Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
216 devices

DISTRIBUTION
Nationwide