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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device refractometer, ophthalmic
Regulation Description Ophthalmic refractometer.
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 28 28
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 65 65
Material Frayed 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Sparking 5 5
Fire 2 2
Insufficient Information 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
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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