Oculus Pentacam AXL optical devices recalled for measurement accuracy issues
Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.
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: FDA Class II recall of an optical measurement device with insufficient anti-reflective coating that may produce incorrect measurements. No hospitalizations or injuries have been reported, but the measurement error poses a potential risk to diagnostic accuracy.
Plain-English summary
The Oculus Pentacam AXL, model Ref 70100, CE 0123, manufactured by Oculus Optikgeraete GMBH, is being recalled. A total of 364 units have been identified with this issue.
The recalled devices may have insufficient anti-reflective coating, which could lead to incorrect axial length measurements.
The devices were distributed nationwide in the United States in the following states: California, Florida, Massachusetts, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, and Washington. The FDA recall number is Z-2483-2023.
The recalled product
- Product
- Oculus Pentacam AXL , Ref 70100, CE 0123
- Manufacturer
- Oculus Optikgeraete GMBH
- Affected units
- 364
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)
- UDI-DI
- (01) 04049584012333
Distribution
Part of a larger recall action
This product is one of 3 recalled by Oculus Optikgeraete GMBH 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.
See all 3 products in this recall →Related recalls
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