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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device lenses, soft contact, extended wear
Regulation Description Soft (hydrophilic) contact lens.
Product CodeLPM
Regulation Number 886.5925
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
26 35 43 79 59 30

Device Problems
Contact Lens 525
No Apparent Adverse Event 365
Adverse Event Without Identified Device or Use Problem 279
Insufficient Information 10
Defective Device 2
Appropriate Term/Code Not Available 2
Use of Device Problem 2
Contamination During Use 2
Improper or Incorrect Procedure or Method 1
Device Operates Differently Than Expected 1
Contamination / decontamination Problem 1
Torn Material 1
Missing Value Reason 1
Sticking 1
Total Device Problems 1193

Recalls
Manufacturer Recall Class Date Posted
1 Cooper Vision Caribbean Corp. II Dec-15-2014
2 CooperVision Inc. III Feb-23-2018
3 Intertrade Imports Inc. II Jan-12-2015
4 Johnson & Johnson Vision Care, Inc. II Mar-27-2018

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