Recall Z-2483-2023— Oculus Optikgeraete GMBH

Name: FDA recall Z-2483-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-08

Class II · Ongoing

Class II FDA medical device recall by Oculus Optikgeraete GMBH, initiated 2023-08-08. It names one FDA 510(k) clearance: K152311. Product: Oculus Pentacam AXL , Ref 70100, CE 0123. Reason: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements..

Recalling firm: Oculus Optikgeraete GMBH
Classification: Class II
Status: Ongoing
Initiated: 2023-08-08
Firm location: Wetzlar, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K152311 — Pentacam AXLOculus Optikgerate GmbH·cleared 2016-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Oculus Pentacam AXL , Ref 70100, CE 0123

Reason for recall

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.