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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
2021 5 5
2023 10 10
2024 28 28
2025 37 37
2026 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 81 81
Material Frayed 13 13
Sparking 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Fire 2 2
Insufficient Information 2 2
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Visual Impairment 2 2
Halo 1 1
Visual Disturbances 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-18-2026
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