FDA Device Intelligence
Home › OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung › Pentacam AXL

Pentacam AXL

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Model 70100 · UDI-DI 04049584012333

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

Description

While rotating around the eye, the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured and displayed by interferometry.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.