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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 lens, intraocular, phakic
Product CodeMTA
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
2 0 5 3 6 1

Device Problems
Inadequacy of Device Shape and/or Size 4886
Appropriate Term/Code Not Available 1476
Device Operates Differently Than Expected 1103
Adverse Event Without Identified Device or Use Problem 437
Off-Label Use 380
Device Dislodged or Dislocated 353
No Apparent Adverse Event 333
Misfocusing 282
Torn Material 167
Unintended Movement 167
Optical Problem 116
Insufficient Information 112
Patient-Device Incompatibility 66
Break 52
Positioning Failure 51
Improper or Incorrect Procedure or Method 33
Device Contamination with Chemical or Other Material 22
Difficult to Fold, Unfold or Collapse 14
Activation Failure 13
Material Opacification 11
Contamination /Decontamination Problem 9
Use of Device Problem 8
Failure to Unfold or Unwrap 7
Positioning Problem 7
Scratched Material 7
Device Markings/Labelling Problem 6
Entrapment of Device 5
Fracture 4
Missing Value Reason 4
Ejection Problem 4
Inaccurate Information 3
Crack 3
Mechanical Jam 3
Sticking 3
Defective Device 3
Difficult To Position 3
Activation, Positioning or SeparationProblem 3
Contamination 3
Optical Decentration 3
Difficult or Delayed Positioning 2
Difficult to Insert 2
Incomplete or Missing Packaging 2
Material Discolored 2
Malposition of Device 2
Packaging Problem 2
Bent 2
Shelf Life Exceeded 2
Device Handling Problem 2
Material Deformation 1
Material Twisted/Bent 1
Cut In Material 1
Material Too Rigid or Stiff 1
Migration or Expulsion of Device 1
Device Issue 1
Difficult to Advance 1
Device Damaged by Another Device 1
Tear, Rip or Hole in Device Packaging 1
Device Contaminated During Manufacture or Shipping 1
Delivered as Unsterile Product 1
Unintended Ejection 1
Mechanical Problem 1
Difficult to Open or Close 1
Difficult to Remove 1
Device Slipped 1
Folded 1
Difficult to Open or Remove Packaging Material 1
Manufacturing, Packaging or Shipping Problem 1
Total Device Problems 10199


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