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Pentacam AXL Wave

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Model 70020 · UDI-DI 04049584025357

MXKHJO Prescription
1
510(k) clearances
12
Adverse events
7
Recalls
18
Facilities

Description

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.

Recalls

DateFirmReason
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2017-11-21Oculus Optikgeraete GMBHThe device software versions have an anomaly which may produce an erroneous marking for the quality specification value

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.