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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, analysis, anterior segment
Product CodeMXK
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
C.S.O. S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
OCULUS OPTIKGERATE GMBH
  SUBSTANTIALLY EQUIVALENT 2
OCULUS OPTIKGERÄTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SANTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIS AG, SURGICAL INSTRUMENT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VISIA IMAGING S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2019 2 2
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Measurement 2 2
Unstable 1 1
Incorrect Or Inadequate Test Results 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 2 2
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Oculus Optikgeraete GMBH II Aug-30-2023
2 Oculus Optikgeraete GMBH II Sep-02-2022
3 Oculus Optikgeraete GMBH II Feb-16-2018
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