Z-2483-2023 Class II Ongoing
FDA device recall Z-2483-2023 was initiated by Oculus Optikgeraete GMBH on Aug 8, 2023 and is designated Class II. Reason for recall: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. The recall status is ongoing. Affected quantity: 364 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 6, 2023
- Initiation Date
- Aug 8, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2483-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026