FDA recall Z-2483-2023

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-08-08

Report date

2023-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wetzlar, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2483-2023