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Oculus Optikgeraete GMBH Recall 92847

Description: Oculus Pentacam AXL , Ref 70100, CE 0123

Oculus Optikgeraete GMBH Recall 92847 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2483-2023
Event ID92847
Event DescriptionOculus Pentacam AXL , Ref 70100, CE 0123
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
Quantity364 units
Recall ReasonTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Device Classification20230906
Device Code InfoUDI-DI; (01) 04049584012333
Center Classification Date20230830
Recall Initiation Date20230808
Recalling FirmOculus Optikgeraete GMBH
Initial Notification Letter
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