Medical device software error affects toric IOL surgical planning accuracy
A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.
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 medical device with a software defect affecting surgical planning calculations, but no reported illnesses or injuries. Qualifies as a risk-of-harm product without reported injury, warranting a score of 3 (High).
Plain-English summary
The Pentacam AXL Wave REF 70020, manufactured by Oculus Optikgeraete GMBH, is a medical device used to image the anterior segment of the eye. The device is used in clinical settings to calculate parameters for surgical planning, including placement of toric intraocular lenses (IOLs).
A software defect has been identified in device versions 1.26r26 and 1.26r27. Due to this software issue, the IOL calculator printout may not accurately reflect the alignment axis and incision position when planning toric IOL surgeries.
Approximately 21 systems with the affected software versions have been distributed across the United States and Puerto Rico. The recalled devices are identified by model number 70020 with specific serial numbers documented in the official recall notice.
The recalled product
- Product
- Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
- Manufacturer
- Oculus Optikgeraete GMBH
- Affected units
- 21
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.
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