Summary
The FDA issued a Class II for Oculus Pentacam AXL , Ref 70100, CE 0123 by Oculus Optikgeraete GMBH. Reason: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements..
Details
Source
Device Recall
External ID
Z-2483-2023
Action Date
2023-09-06
Status
Ongoing
Category
device
Product Description
Oculus Pentacam AXL , Ref 70100, CE 0123
Lot/Code Info: UDI-DI; (01) 04049584012333
Quantity Affected: 364 units
Reason for Recall
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Distribution
US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-08
Company
Wetzlar, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Oculus Optikgeraete GMBH has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oculus Optikgeraete GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oculus Optikgeraete GMBH have FDA actions?
Oculus Optikgeraete GMBH has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2483-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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