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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
2014 1 1
2015 4 4
2016 9 9
2017 10 10
2018 9 9
2020 7 7
2021 5 5
2023 10 10
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Material Split, Cut or Torn 11 11
Material Frayed 6 6
Device Operates Differently Than Expected 5 5
Smoking 2 2
Insufficient Information 1 1
Human-Device Interface Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 25 25
No Clinical Signs, Symptoms or Conditions 14 14
Visual Impairment 13 13
Visual Disturbances 3 3
No Known Impact Or Consequence To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Corneal Clouding/Hazing 2 2
Keratitis 2 2
Pain 1 1
Therapeutic Effects, Unexpected 1 1
Unspecified Infection 1 1
Erosion 1 1
Corneal Ulcer 1 1
Dry Eye(s) 1 1
Edema 1 1
Eye Injury 1 1
Flashers 1 1
Halo 1 1
Anxiety 1 1
Discomfort 1 1
Wrinkling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Inc. II May-25-2013
2 Carl Zeiss Meditec AG II Dec-16-2020
3 Nidek Inc II Aug-27-2015
4 Nidek Inc. II Apr-10-2018
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