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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, intraocular, toric optics
Product CodeMJP
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
1 1 0 1 0 0

MDR Year MDR Reports MDR Events
2017 311 311
2018 364 364
2019 382 382
2020 211 211
2021 285 288
2022 267 267

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 512 512
Scratched Material 170 170
Appropriate Term/Code Not Available 142 142
Break 126 129
Device Operates Differently Than Expected 98 98
Insufficient Information 94 94
Device Dislodged or Dislocated 91 91
Defective Device 66 66
Crack 56 56
Patient-Device Incompatibility 45 45
Unstable 43 43
Malposition of Device 33 33
Unexpected Therapeutic Results 28 28
Device Contamination with Chemical or Other Material 26 26
Positioning Problem 25 25
Material Split, Cut or Torn 24 24
Defective Component 23 23
Unintended Movement 21 21
Material Opacification 21 21
Mechanical Problem 15 15
Inaccurate Delivery 14 14
Contamination /Decontamination Problem 14 14
Material Fragmentation 13 13
Failure to Advance 13 13
Mechanical Jam 12 12
Power Problem 10 10
Material Deformation 10 10
Therapeutic or Diagnostic Output Failure 10 10
Failure to Align 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Difficult to Fold, Unfold or Collapse 9 9
Material Discolored 8 8
Improper or Incorrect Procedure or Method 8 8
Device Contaminated During Manufacture or Shipping 8 8
Physical Resistance/Sticking 8 8
Migration or Expulsion of Device 8 8
Failure to Unfold or Unwrap 8 8
Device Markings/Labelling Problem 7 7
Migration 7 7
Contamination 7 7
Material Twisted/Bent 6 6
Torn Material 6 6
Output Problem 6 6
Overcorrection 6 6
Device Slipped 5 5
Delivered as Unsterile Product 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Operating System Becomes Nonfunctional 4 4
Material Too Rigid or Stiff 4 4
Device Displays Incorrect Message 4 4
Application Program Problem: Power Calculation Error 4 4
Activation, Positioning or SeparationProblem 4 4
Use of Device Problem 4 4
Component Missing 3 3
Device Difficult to Setup or Prepare 3 3
Detachment of Device or Device Component 3 3
Structural Problem 3 3
Failure to Eject 3 3
Difficult to Advance 3 3
Difficult to Insert 3 3
Device Damaged Prior to Use 3 3
Out-Of-Box Failure 3 3
Folded 3 3
Device Damaged by Another Device 3 3
Device Inoperable 3 3
Material Integrity Problem 3 3
Optical Problem 2 2
Compatibility Problem 2 2
Sticking 2 2
Off-Label Use 2 2
Optical Discoloration 2 2
Optical Distortion 2 2
Component Falling 2 2
Application Program Problem: Dose Calculation Error 2 2
Entrapment of Device 2 2
Failure to Fold 2 2
Unable to Obtain Readings 2 2
Ejection Problem 2 2
Split 1 1
Blocked Connection 1 1
Packaging Problem 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Failure to Deliver 1 1
Microbial Contamination of Device 1 1
Particulates 1 1
Premature Activation 1 1
Collapse 1 1
Degraded 1 1
Fogging 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Rupture 1 1
Difficult or Delayed Positioning 1 1
Kinked 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
Device Alarm System 1 1
Patient Device Interaction Problem 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 378 378
Blurred Vision 300 300
No Known Impact Or Consequence To Patient 261 261
No Clinical Signs, Symptoms or Conditions 241 241
No Code Available 203 203
Visual Disturbances 100 100
Insufficient Information 78 78
Inflammation 71 71
Capsular Bag Tear 58 58
Failure of Implant 57 57
Halo 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 52 52
Endophthalmitis 43 43
No Consequences Or Impact To Patient 36 39
Loss of Vision 33 33
Corneal Edema 29 30
Pain 28 30
Therapeutic Effects, Unexpected 25 25
Eye Injury 20 20
Vitrectomy 19 19
No Information 19 19
Dry Eye(s) 18 18
Discomfort 17 17
Intraocular Pressure Increased 12 12
Red Eye(s) 11 12
Complaint, Ill-Defined 11 11
No Patient Involvement 11 11
Headache 10 10
Hypopyon 10 10
Eye Pain 9 9
Therapeutic Response, Decreased 8 8
Patient Problem/Medical Problem 7 7
Uveitis 7 7
Corneal Clouding/Hazing 7 7
Unspecified Infection 6 6
Zonular Dehiscence 6 6
Increased Sensitivity 6 6
Rupture 6 6
Macular Edema 6 6
Foreign Body Sensation in Eye 6 6
Fibrosis 5 5
Toxic Anterior Segment Syndrome (TASS) 5 5
Dizziness 4 4
Foreign Body In Patient 4 4
Edema 3 3
Hemorrhage/Bleeding 3 3
Hyperemia 3 3
Vitreous Floaters 3 3
Itching Sensation 3 3
Scar Tissue 3 3
Scarring 3 3
Erythema 3 3
Vitreous Loss 3 3
Unspecified Eye / Vision Problem 3 3
Toxicity 3 3
Iritis 2 2
Vitreous Detachment 2 2
Flashers 2 2
Swelling 2 2
Inadequate Pain Relief 2 2
Tissue Damage 1 1
Bacterial Infection 1 1
Bone Fracture(s) 1 1
Nausea 1 1
Necrosis 1 1
Optical Nerve Damage 1 1
Swelling/ Edema 1 1
Skin Inflammation 1 1
Fluid Discharge 1 1
Conjunctivitis 1 1
Deposits 1 1
Glaucoma 1 1
Retinal Tear 1 1
Blood Loss 1 1
Adhesion(s) 1 1
Burning Sensation 1 1
Retinal Detachment 1 1
Depression 1 1
Reaction 1 1
Keratitis 1 1
Hyphema 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Vitritis 1 1
Excessive Tear Production 1 1
Fatigue 1 1
Intraocular Infection 1 1
Corneal Stromal Edema 1 1
Autoimmune Reaction 1 1
Calcium Deposits/Calcification 1 1
Corneal Decompensation 1 1
Joint Dislocation 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Surgical, Inc. II Dec-02-2020
2 Johnson & Johnson Surgical Vision Inc II Oct-04-2021
3 Johnson & Johnson Surgical Vision Inc II Mar-03-2021
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