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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
Regulation Description Manual refractor.
Product CodeHKN
Regulation Number 886.1770
Device Class 1

Device Problems
Detachment Of Device Component 24
Holder 24
Hinge 21
Device Component Or Accessory 3
Total Device Problems 72

Recalls
Manufacturer Recall Class Date Posted
1 Nidek Inc II Mar-24-2016
2 Nidek Inc. III Dec-21-2018
3 Reliance Medical Products Inc II Apr-09-2018

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