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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, ophthalmic, posterior capsular polishing, polyvinyl acetal
Regulation Description Manual ophthalmic surgical instrument.
Product CodeMXY
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vortex Surgical Inc. II Feb-04-2026
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