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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, iris retractor
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHOC
Regulation Number 886.4350
Device Class 1

Device Problems
Material Separation 12
Loss of or Failure to Bond 4
Retraction Problem 4
Adverse Event Without Identified Device or Use Problem 4
Use of Device Problem 1
Device Operational Issue 1
Total Device Problems 26


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