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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
Regulation Description 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)
2020 2021 2022 2023 2024 2025
3 1 6 3 0 0

MDR Year MDR Reports MDR Events
2020 347 358
2021 598 599
2022 635 635
2023 552 552
2024 565 580
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1737 1747
Scratched Material 233 233
Device Dislodged or Dislocated 104 104
Defective Device 103 103
Break 97 109
Appropriate Term/Code Not Available 74 74
Crack 59 59
Device Contamination with Chemical or Other Material 39 39
Malposition of Device 36 36
Unstable 34 34
Material Opacification 27 27
Material Split, Cut or Torn 26 26
Defective Component 24 24
Failure to Eject 24 24
Unintended Movement 24 24
Insufficient Information 20 20
Device Damaged by Another Device 18 18
Failure to Advance 15 15
Optical Decentration 13 13
Application Program Problem: Power Calculation Error 12 12
Use of Device Problem 11 11
Contamination 10 10
Inaccurate Delivery 8 8
Material Fragmentation 8 8
Mechanical Problem 8 8
Material Discolored 8 8
Device Markings/Labelling Problem 7 7
Patient-Device Incompatibility 7 7
Failure to Unfold or Unwrap 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Difficult to Fold, Unfold or Collapse 6 6
Application Program Problem: Dose Calculation Error 6 6
Material Twisted/Bent 5 5
Device Difficult to Setup or Prepare 5 5
Product Quality Problem 5 5
Structural Problem 5 5
Material Deformation 5 5
Failure to Fold 4 4
Physical Resistance/Sticking 4 5
Failure to Align 4 4
Mechanical Jam 3 3
Difficult to Insert 3 3
Nonstandard Device 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Positioning Problem 2 2
Positioning Failure 2 2
Ejection Problem 2 2
Patient Device Interaction Problem 2 2
Difficult to Advance 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 957 958
Visual Impairment 691 691
Visual Disturbances 678 684
No Clinical Signs, Symptoms or Conditions 362 363
Halo 359 361
Insufficient Information 355 355
No Code Available 262 262
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 202 202
Dry Eye(s) 78 78
Flashers 57 59
Discomfort 56 56
Headache 51 51
Eye Pain 47 47
Corneal Edema 44 44
Eye Injury 42 42
Inflammation 40 40
Therapeutic Effects, Unexpected 36 36
Capsular Bag Tear 31 31
Vitreous Floaters 29 29
Macular Edema 24 24
Unspecified Eye / Vision Problem 21 21
Dizziness 16 16
Nausea 14 14
Vitrectomy 14 14
No Consequences Or Impact To Patient 13 25
Intraocular Pressure Increased 13 13
Foreign Body Sensation in Eye 11 11
Excessive Tear Production 10 10
Uveitis 10 10
Pain 9 9
Zonular Dehiscence 8 8
Endophthalmitis 8 8
Conjunctivitis 7 7
No Known Impact Or Consequence To Patient 6 6
Swelling/ Edema 6 6
Itching Sensation 6 6
Toxic Anterior Segment Syndrome (TASS) 6 6
Irritability 6 6
Unspecified Infection 5 5
Iritis 5 5
Red Eye(s) 5 5
Failure of Implant 4 4
Fibrosis 3 3
Balance Problems 3 3
Intraocular Pressure Decreased 3 3
Vitreous Detachment 3 3
Retinal Tear 3 3
Unspecified Tissue Injury 3 3
Hypersensitivity/Allergic reaction 3 3
Hemorrhage/Bleeding 3 3

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