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.
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 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
Same manufacturer · Oculus Optikgeraete GMBH
See all →- HighOculus Pentacam AXL optical devices recalled for measurement accuracy issues
FDA (Devices) · 2023-09-06
- HighOculus Myopia Master optical device recalled for insufficient anti-reflective coating
FDA (Devices) · 2023-09-06
- HighMedical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy
FDA (Devices) · 2023-09-06
- HighEye imaging device software defect affects surgical planning calculations
FDA (Devices) · 2022-09-07
- HighMedical device software error affects toric IOL surgical planning accuracy
FDA (Devices) · 2022-09-07
Same hazard · software error
See all →- HighQuantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
FDA (Devices) · 2026-08-12
- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighQuantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk
FDA (Devices) · 2026-08-12
- HighREMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
FDA (Devices) · 2026-08-12
- HighQuantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
FDA (Devices) · 2026-08-12