Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2411-2012·Announced 2012-09-26

Haag-Streit Recalls Octopus 101 Perimeters Due to Luminance Deviation

Haag-Streit USA Inc recalled 64 Octopus 101 Perimeters because of a possible deviation in stimulus luminance. The devices are used to determine the extent of a patient's peripheral visual field.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a 'possible deviation' in luminance without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not yet been reported.

Plain-English summary

Haag-Streit USA Inc is recalling 64 units of the Octopus 101 Perimeter. The company initiated the recall after learning of a possible deviation in the stimulus luminance of the device. The Octopus 101 is a medical device intended to determine the extent of the peripheral visual field of a patient by projecting light on various points of a curved surface.

The affected devices are Model Octopus 101 with specific serial numbers listed in the recall notice. The units were distributed worldwide, including nationwide in the United States and to Jamaica, Puerto Rico, and Mexico. The recall is classified as Class II by the FDA.

Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions on how to proceed. The recall is voluntary and precautionary, as no specific injuries or illnesses have been reported in the source text.

The recalled product

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…
Manufacturer: Haag-Streit USA Inc
Category: Medical Device — Ophthalmic Diagnostic
Hazard: inaccurate-diagnostic
Affected units: 64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Octopus 101. SN: 119
136
165
166
221
222
225
236
243
273
277
279
370
371
392
507
541
553
570
602

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Same manufacturer · Haag-Streit USA Inc

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