Company: Haag-Streit USA Inc.
Date of Enforcement Report 7/21//2010
Class ll:
PRODUCT
Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal. Recall # Z-1897-2010.
REASON
During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect intra-ocular lens (IOL).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haag-Streit USA Inc., Mason, OH, by letters beginning May 19, 2010.
Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide
