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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, multifocal intraocular
Regulation Description Intraocular lens.
Product CodeMFK
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
5 3 11 12 12 6

Device Problems
Adverse Event Without Identified Device or Use Problem 1014
Nonstandard device 79
Inadequacy of Device Shape and/or Size 69
Device Operates Differently Than Expected 62
Appropriate Term/Code Not Available 55
Insufficient Information 50
Unintended Movement 47
Scratched Material 35
IOL (Intraocular Lens) Implant 32
Device Dislodged or Dislocated 27
Break 24
Device Contamination with Chemical or Other Material 21
Torn Material 19
Migration or Expulsion of Device 17
Material Opacification 10
Crack 8
Malposition of device 7
Difficult or Delayed Positioning 7
Bent 6
Patient-Device Incompatibility 6
Failure to Unfold or Unwrap 6
Positioning Problem 5
Haptic 4
Detachment Of Device Component 4
Product Quality Problem 4
Invalid Sensing 4
Contamination / decontamination Problem 3
Use of Device Problem 3
Incorrect Measurement 3
Optical Decentration 3
Difficult to Fold or Unfold 3
Sticking 3
Material Deformation 2
Positioning Failure 2
Device Damaged by Another Device 2
Device Handling Problem 2
Material Distortion 2
Difficult to Insert 2
Kinked 2
Separation Problem 2
Mechanical Problem 2
Improper or Incorrect Procedure or Method 2
Material Puncture / Hole 2
Degraded 2
Suction Problem 2
Material Split, Cut or Torn 2
Device Tipped Over 1
Therapeutic or Diagnostic Output Failure 1
Delivered as Unsterile Product 1
Defective Component 1
Flare or Flash 1
Improper Device Output 1
Unexpected Therapeutic Results 1
Unstable 1
Valve 1
Contamination During Use 1
Human-Device Interface Problem 1
Material Twisted / Bent 1
Fracture 1
Wrinkled 1
Difficult To Position 1
Delivery System Failure 1
Material Rupture 1
Device Damaged Prior to Use 1
Device Markings / Labelling Problem 1
Expulsion 1
Air Leak 1
Material Too Rigid or Stiff 1
Total Device Problems 1690


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