Medical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy
Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.
What this means for you
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 risk-of-harm medical device where injury has not yet been reported. The potential for inaccurate measurements could affect surgical outcomes, but no illnesses or injuries have been documented in the source text. FDA Class II classification supports the High rating rather than Moderate.
Plain-English summary
Oculus Optikgeraete GMBH is recalling 143 units of the Oculus Pentacam AXL Wave (Ref 70020, CE 0123) distributed nationwide across the United States.
The devices may have insufficient anti-reflective coating, which could lead to incorrect axial length measurements. Axial length is a critical measurement used in planning eye surgeries and fitting intraocular lenses.
The affected devices were distributed in California, Florida, Massachusetts, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, and Washington. Healthcare facilities that use this device should verify their unit serial numbers against the recalled product identifiers (UDI-DI: 04049584025357) and contact the manufacturer for guidance on corrections or replacements.
The recalled product
- Product
- Oculus Pentacam AXL Wave, Ref 70020, CE 0123
- Manufacturer
- Oculus Optikgeraete GMBH
- Hazard
- measurement-inaccuracy
- optical-coating-defect
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) 04049584025357
Distribution
Distributed nationwide across the United States.
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