OCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk
Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a medical device with a safety-critical malfunction: the automatic laser beam shut-off may fail to function properly. While no injuries have been reported, the hazard poses a direct risk of harm from uncontrolled laser operation.
Plain-English summary
Haag-Streit USA Inc is recalling OCT-Camera 211 01 A1 devices running iOCT-Control 3 v1.4 software. Two devices have been quarantined in the United States (serial numbers 0005 and 0023).
The automatic laser beam shut-off feature may malfunction, and the device may not properly recognize whether the laser beam is safely switched off. This creates a potential risk of continued laser operation when the beam should be disabled.
The affected devices were distributed nationwide in Ohio and Indiana. This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
- Manufacturer
- Haag-Streit USA Inc
- Affected units
- 2
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 (2)
- Serial no. 0005
- 0023
Distribution
Part of a larger recall action
This product is one of 2 recalled by Haag-Streit USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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