Pentacam HR Medical Device Software Error Impacts Surgical Planning
A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.
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 FDA Class II device involves a software accuracy issue in a surgical planning tool with potential to affect surgical outcomes. No injuries or illnesses have been reported, placing this in the 'risk-of-harm' category where no actual harm has yet occurred.
Plain-English summary
The Pentacam HR REF 70900, manufactured by Oculus Optikgeraete GMBH, is an eye imaging system used to plan intraocular lens (IOL) implantation surgery. The device has been recalled due to a software defect affecting IOL calculator output.
The software issue causes the calculator to display inaccurate alignment axis and incision position information when planning toric IOLs (specialty lenses used to correct astigmatism). This inaccuracy could affect the precision of surgical planning if the information is used without verification.
Nineteen systems with software versions 1.26r26 and 1.26r27 are affected. The recalled systems were distributed across multiple U.S. states and Puerto Rico. Users of affected devices should contact the manufacturer for a software update.
Oculus Optikgeraete GMBH is responsible for implementing corrective actions. No injuries or illnesses have been reported.
The recalled product
- Product
- Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Manufacturer
- Oculus Optikgeraete GMBH
- Affected units
- 19
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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