Home / Recalls / Oculus Optikgeraete GMBH / Z-2483-2023

Z-2483-2023 Class II Ongoing

Recalled by Oculus Optikgeraete GMBH — Wetzlar, N/A

Recall Details

Product Type
Devices
Report Date
September 6, 2023
Initiation Date
August 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
364 units

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.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided

Code Information

UDI-DI; (01) 04049584012333

Other recalls by Oculus Optikgeraete GMBH

  • Z-2484-2023 Class II — Oculus Myopia Master , Ref 68100, CE 0123 (August 8, 2023)
  • Z-2482-2023 Class II — Oculus Pentacam AXL Wave, Ref 70020, CE 0123 (August 8, 2023)
  • Z-1672-2022 Class II — Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. (July 8, 2022)
  • Z-1674-2022 Class II — Pentacam HR REF 70900. Used to image the anterior segment of the eye. (July 8, 2022)
  • Z-1673-2022 Class II — Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior se (July 8, 2022)
  • Z-0635-2018 Class II — OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, a (November 21, 2017)