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.
What this means for you
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 light.
- Manufacturer
- Haag-Streit USA Inc
- Hazard
- 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
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