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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device refractor, manual, non-powered, including phoropter
Product CodeHKN
Regulation Number 886.1770
Device Class 1

MDR Year MDR Reports MDR Events
2014 14 14
2015 3 3
2016 1 1
2017 19 19
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 31 31
Component Falling 3 3
Nonstandard Device 2 2
Device Handling Problem 2 2
Unintended Collision 1 1
Insufficient Information 1 1
Unintended Electrical Shock 1 1
Bent 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Code Available 16 16
Laceration(s) 9 9
Bruise/Contusion 6 6
Eye Injury 2 2
Corneal Abrasion 1 1
Undesired Nerve Stimulation 1 1
Pain 1 1
Scar Tissue 1 1
Injury 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nidek Inc II Mar-24-2016
2 Nidek Inc II Jun-23-2014
3 Nidek Inc. III Dec-21-2018
4 Reichert, Inc. II Aug-31-2023
5 Reliance Medical Products Inc II Apr-09-2018
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