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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
Definition Intended to be implanted to replace the natural lens of an eye.
Product CodePOE
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 1 0 0 0 3 1 6 3 0

MDR Year MDR Reports MDR Events
2016 110 110
2017 754 754
2018 799 799
2019 735 819
2020 347 358
2021 598 599
2022 635 635
2023 552 552
2024 391 401

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3426 3434
Scratched Material 238 238
Inadequacy of Device Shape and/or Size 180 180
Unintended Movement 161 161
Appropriate Term/Code Not Available 158 158
Device Dislodged or Dislocated 126 126
Break 112 208
Defective Device 95 95
Crack 68 68
Device Contamination with Chemical or Other Material 67 67
Malposition of Device 39 39
Unstable 32 32
Material Opacification 29 29
Material Split, Cut or Torn 26 26
Mechanical Problem 21 21
Defective Component 19 19
Migration or Expulsion of Device 19 19
Insufficient Information 19 19
Failure to Eject 15 15
Failure to Advance 14 14
Contamination 14 14
Device Damaged by Another Device 13 13
Application Program Problem: Power Calculation Error 12 12
Optical Decentration 12 12
Use of Device Problem 12 12
Contamination /Decontamination Problem 11 11
Torn Material 10 10
Device Markings/Labelling Problem 10 10
Product Quality Problem 9 9
Failure to Unfold or Unwrap 9 9
Invalid Sensing 9 9
Patient-Device Incompatibility 9 9
Inaccurate Delivery 8 8
Material Fragmentation 8 8
Difficult to Fold, Unfold or Collapse 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Unexpected Therapeutic Results 6 6
Material Discolored 6 6
Dent in Material 6 6
Difficult to Insert 6 6
Application Program Problem: Dose Calculation Error 6 6
Structural Problem 5 5
Material Deformation 5 5
Incorrect Measurement 5 5
Material Twisted/Bent 4 4
Failure to Align 4 4
Positioning Problem 4 4
Device Operates Differently Than Expected 3 3
Patient Device Interaction Problem 3 3
Device Difficult to Setup or Prepare 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2253 2253
Blurred Vision 1256 1257
Visual Disturbances 1147 1152
Halo 921 922
Visual Impairment 916 916
No Clinical Signs, Symptoms or Conditions 321 321
Insufficient Information 306 306
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 200 200
Dry Eye(s) 124 124
Capsular Bag Tear 68 68
No Consequences Or Impact To Patient 65 161
Discomfort 64 64
Vitrectomy 63 63
Headache 60 60
Corneal Edema 59 59
Flashers 59 61
Inflammation 55 55
No Patient Involvement 53 53
No Known Impact Or Consequence To Patient 49 49
Eye Pain 44 44
Eye Injury 42 42
Therapeutic Effects, Unexpected 36 36
Vitreous Floaters 36 36
Macular Edema 29 29
Pain 25 25
Intraocular Pressure Increased 23 23
Foreign Body Sensation in Eye 20 20
Dizziness 19 19
Endophthalmitis 18 18
Nausea 17 17
Unspecified Eye / Vision Problem 17 17
Uveitis 12 12
Irritation 12 12
Red Eye(s) 11 11
Excessive Tear Production 10 10
Unspecified Infection 10 10
Zonular Dehiscence 8 8
Itching Sensation 7 7
No Information 7 7
Glaucoma 7 7
Iritis 7 7
Retinal Detachment 7 7
Conjunctivitis 7 7
Swelling/ Edema 6 6
Toxic Anterior Segment Syndrome (TASS) 6 6
Irritability 6 6
Keratitis 4 4
Failure of Implant 4 4
Swelling 4 4
Fibrosis 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision, Inc. II Aug-03-2023
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