Company:Haag-Streit USA Inc.
Date of Enforcement Report 9/26/12
Class ll:

PRODUCT

Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light. Recall Number Z-2411-2012

REASON
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

RECALLING FIRM/MANUFACTURER
Haag-Streit USA Inc., Mason, OH on 8/17/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
64 units

DISTRIBUTION
Nationwide and to the countries of Jamaica, Puerto Rico, and Mexico

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