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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trabeculotome
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHMZ
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2023 1 1
2025 11 11
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Material Fragmentation 6 6
Insufficient Device Problem Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Eye Injury 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Hyphema 5 5
Unspecified Eye / Vision Problem 2 2
Intraocular Pressure Increased 1 1
Nausea 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Eye Pain 1 1
Prolapse 1 1
Intraocular Pressure Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Iantrek Inc. II Oct-10-2025
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