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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Material Frayed 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Code Available 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Visual Impairment 3 3
Visual Disturbances 1 1
Halo 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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