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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intraocular lens
Regulation Description Intraocular lens.
Product CodeHQL
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
18 27 49 41 39 44

Device Problems
Adverse Event Without Identified Device or Use Problem 2987
Packaging Problem 2257
Leak / Splash 2220
IOL (Intraocular Lens) Implant 1202
Break 946
Appropriate Term/Code Not Available 672
Device Contamination with Chemical or Other Material 513
Scratched Material 397
Torn Material 370
Unintended Movement 353
Material Opacification 346
Device Operates Differently Than Expected 339
Crack 309
Sticking 255
Difficult or Delayed Positioning 231
Positioning Failure 211
Inadequacy of Device Shape and/or Size 182
Malposition of device 146
Device Dislodged or Dislocated 145
Bent 138
Failure to Unfold or Unwrap 133
No Apparent Adverse Event 129
Difficult to Fold or Unfold 127
Failure to Eject 105
Insufficient Information 101
Haptic 93
Detachment Of Device Component 92
Use of Device Problem 85
Contamination During Use 85
Material Deformation 84
Contamination / decontamination Problem 84
Material Twisted / Bent 76
Mechanical Jam 74
Material Split, Cut or Torn 65
Physical Resistance / Sticking 65
Separation Problem 60
Split 59
Premature Activation 56
Failure to Fold 56
Fracture 54
Material Integrity Problem 47
Positioning Problem 46
Entrapment of Device 46
Device Handling Problem 46
Defective Device 43
Calcified 42
Activation, Positioning or Separation Problem 40
Detachment of Device or device Component 39
Device Damaged by Another Device 39
Failure to Advance 37
Optical Problem 34
Difficult to Advance 30
Material Distortion 28
Difficult to Insert 26
Inadequate Instructions for Healthcare Professional 25
Kinked 24
Device Markings / Labelling Problem 24
Device Damaged Prior to Use 21
Product Quality Problem 21
Improper or Incorrect Procedure or Method 20
Migration or Expulsion of Device 20
Deformation Due to Compressive Stress 20
Injection System 19
Patient-Device Incompatibility 18
Difficult To Position 18
Lenses 17
Dent in Material 15
Inaccurate Delivery 14
Manufacturing, Packaging or Shipping Problem 14
Mechanical Problem 13
Delivery System Failure 12
Failure to Deliver 12
Ejection Problem 12
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 11
Optical Decentration 11
Material Discolored 10
Wrinkled 10
Material Separation 10
Component Missing 10
Cut In Material 9
Partial Blockage 9
Material Too Rigid or Stiff 8
Material Rupture 8
Folded 8
Optical Discoloration 8
Plunger 8
Physical Resistance 7
Invalid Sensing 7
Device Abrasion From Instrument Or Another Object 7
Delivered as Unsterile Product 7
Unsealed Device Packaging 7
Material Frayed 7
Incorrect Measurement 6
Device Packaging Compromised 6
Sharp Edges 6
Material Protrusion / Extrusion 5
Hole In Material 5
Unintended Ejection 4
Material Fragmentation 4
Particulates 4
Total Device Problems 16986

Recalls
Manufacturer Recall Class Date Posted
1 AMO Puerto Rico Manufacturing, Inc. II Aug-26-2014
2 AMO Puerto Rico Manufacturing, Inc. II Mar-03-2014
3 Aaren Scientific, Incorporated II Mar-20-2015
4 Abbott Medical Optics Inc. (AMO) II Sep-21-2016
5 Alcon Research, Ltd. II Sep-01-2016
6 Alcon Research, Ltd. I Nov-25-2015
7 Alcon Research, Ltd. I Aug-07-2015
8 Bausch & Lomb Surgical, Inc. II Dec-18-2018
9 Bausch & Lomb Surgical, Inc. II Jul-20-2015
10 Bausch & Lomb Surgical, Inc. II Feb-20-2014
11 Johnson & Johnson Surgical Vision Inc II Nov-14-2018
12 Rayner Intraocular Lenses Limited II Sep-28-2018
13 Tekia, Inc. II Nov-06-2015

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