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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device refractometer, ophthalmic
Product CodeHKO
Regulation Number 886.1760
Device Class 1

MDR Year MDR Reports MDR Events
2020 7 7
2021 5 5
2023 10 10
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 27 27
Material Frayed 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
No Code Available 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Visual Impairment 3 3
Halo 1 1
Visual Disturbances 1 1
Therapeutic Effects, Unexpected 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Dec-16-2020
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