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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)
2019 2020 2021 2022 2023 2024
0 3 1 6 3 0

MDR Year MDR Reports MDR Events
2019 735 819
2020 347 358
2021 598 599
2022 635 635
2023 552 552
2024 429 439

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2260 2268
Scratched Material 205 205
Device Dislodged or Dislocated 112 112
Break 101 197
Defective Device 95 95
Appropriate Term/Code Not Available 91 91
Unintended Movement 69 69
Crack 56 56
Device Contamination with Chemical or Other Material 39 39
Malposition of Device 37 37
Unstable 32 32
Material Opacification 26 26
Material Split, Cut or Torn 26 26
Defective Component 20 20
Insufficient Information 19 19
Failure to Eject 16 16
Mechanical Problem 16 16
Device Damaged by Another Device 15 15
Failure to Advance 14 14
Contamination 13 13
Use of Device Problem 12 12
Application Program Problem: Power Calculation Error 12 12
Optical Decentration 11 11
Material Fragmentation 8 8
Product Quality Problem 8 8
Inaccurate Delivery 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Failure to Unfold or Unwrap 7 7
Patient-Device Incompatibility 7 7
Device Markings/Labelling Problem 7 7
Contamination /Decontamination Problem 6 6
Material Discolored 6 6
Application Program Problem: Dose Calculation Error 6 6
Difficult to Fold, Unfold or Collapse 6 6
Inadequacy of Device Shape and/or Size 5 5
Unexpected Therapeutic Results 5 5
Structural Problem 5 5
Failure to Align 4 4
Material Deformation 4 4
Material Twisted/Bent 3 3
Positioning Problem 3 3
No Apparent Adverse Event 3 3
Dent in Material 3 3
Device Difficult to Setup or Prepare 3 3
Difficult to Insert 3 3
Labelling, Instructions for Use or Training Problem 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Particulates 2 2
Failure to Fold 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 1045 1046
No Code Available 881 881
Visual Disturbances 816 821
Visual Impairment 724 724
Halo 535 536
No Clinical Signs, Symptoms or Conditions 326 326
Insufficient Information 312 312
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 201 201
Dry Eye(s) 97 97
Flashers 56 58
Discomfort 53 53
Headache 52 52
Corneal Edema 51 51
Capsular Bag Tear 47 47
Eye Pain 46 46
Eye Injury 42 42
Inflammation 42 42
Therapeutic Effects, Unexpected 36 36
Vitrectomy 31 31
No Consequences Or Impact To Patient 31 127
Vitreous Floaters 30 30
Macular Edema 26 26
Intraocular Pressure Increased 19 19
Unspecified Eye / Vision Problem 17 17
Dizziness 16 16
Pain 15 15
Foreign Body Sensation in Eye 15 15
Nausea 15 15
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 11 11
Endophthalmitis 10 10
Excessive Tear Production 10 10
Red Eye(s) 8 8
Uveitis 8 8
Zonular Dehiscence 7 7
Conjunctivitis 7 7
Itching Sensation 6 6
Toxic Anterior Segment Syndrome (TASS) 6 6
Irritation 6 6
Irritability 6 6
Swelling/ Edema 6 6
Unspecified Infection 5 5
Glaucoma 5 5
Iritis 5 5
Failure of Implant 4 4
Hemorrhage/Bleeding 3 3
Intraocular Pressure Decreased 3 3
Corneal Abrasion 3 3
Hypersensitivity/Allergic reaction 3 3
Swelling 3 3

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