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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 68
Unintended movement 12
Size incorrect for patient 8
No code available 6
Foreign material present in device 4
Scratched material 3
Torn material 3
Incorrect measurement 2
Break 2
Crack 1
Difficult to deploy 1
Kinked 1
Optical decentration 1
Physical resistance 1
Malposition of device 1
Device operates differently than expected 1
Unsealed device packaging 1
Total Device Problems 116

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