PlainRecalls
FDA Devices Moderate Class II Ongoing

Oculus Pentacam AXL , Ref 70100, CE 0123

Reported: September 6, 2023 Initiated: August 8, 2023 #Z-2483-2023

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.

Details

Recalling Firm
Oculus Optikgeraete GMBH
Units Affected
364 units
Distribution
US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Location
Wetzlar, N/A

Frequently Asked Questions

What product was recalled?
Oculus Pentacam AXL , Ref 70100, CE 0123. Recalled by Oculus Optikgeraete GMBH. Units affected: 364 units.
Why was this product recalled?
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2483-2023.