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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device extended depth of focus intraocular lens
Regulation Description Intraocular lens.
Definition Intended to be implanted to replace the natural lens of an eye.
Product CodePOE
Regulation Number 886.3600
Device Class 3

Device Problems
No Known Device Problem 87
Unintended movement 15
Size incorrect for patient 13
No code available 7
Scratched material 5
Foreign material present in device 4
Torn material 3
Break 3
Incorrect measurement 2
Unsealed device packaging 1
Crack 1
Difficult to deploy 1
Kinked 1
Optical decentration 1
Physical resistance 1
Malposition of device 1
Device markings issue 1
Device operates differently than expected 1
Total Device Problems 148

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