Pentacam AXL Wave 70020Recalls & reported problems
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Aug 8, 2023Class IIOpen, Classified
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Z-2482-2023 · Root cause: Process control · Recall details · FDA record ↗
- Jul 8, 2022Class IIOpen, Classified
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1672-2022 · Root cause: Software design · Recall details · FDA record ↗
Other Device, Analysis, Anterior Segment devices
- Pentacam AXL 70100OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Device,Analysis,Anterior Segment2 recalls0 reports
- Pentacam HR 70900OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Device,Analysis,Anterior Segment1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page