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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ophthalmoscope, ac-powered
Product CodeHLI
Regulation Number 886.1570
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Electrical Shock 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 3 3
Eye Pain 2 2
Sleep Dysfunction 1 1
Electric Shock 1 1
Nausea 1 1
Unspecified Eye / Vision Problem 1 1
Pain 1 1
Tinnitus 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Haag-Streit USA Inc II Jan-10-2022
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