Sep

2012

Cl ll Octopus 101 Perimeter; PeriTrend Software

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll Octopus 101 Perimeter; PeriTrend Software

Amy Sellers

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