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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device phakic toric intraocular lens
Regulation Description Intraocular lens.
Definition Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Product CodeQCB
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
0 0 0 1 0 0

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2017 19 19
2018 10 10
2019 1102 1102
2020 1338 1338

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 1664 1664
Off-Label Use 476 476
Device Dislodged or Dislocated 357 357
Misfocusing 298 298
No Apparent Adverse Event 238 238
Adverse Event Without Identified Device or Use Problem 103 103
Patient-Device Incompatibility 61 61
Optical Problem 58 58
Unintended Movement 25 25
Improper or Incorrect Procedure or Method 20 20
Appropriate Term/Code Not Available 7 7
Ejection Problem 5 5
Insufficient Information 4 4
Material Opacification 4 4
Difficult to Fold, Unfold or Collapse 4 4
Material Split, Cut or Torn 3 3
Patient Device Interaction Problem 1 1
Break 1 1
Optical Decentration 1 1
Failure to Unfold or Unwrap 1 1
Product Quality Problem 1 1
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1762 1762
Blurred Vision 306 306
No Known Impact Or Consequence To Patient 255 255
No Clinical Signs, Symptoms or Conditions 215 215
Intraocular Pressure Increased 164 164
No Consequences Or Impact To Patient 113 113
Visual Disturbances 88 88
Halo 58 58
No Patient Involvement 39 39
Cataract 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Corneal Edema 26 26
Pain 19 19
Headache 15 15
Discomfort 11 11
Inflammation 10 10
Vomiting 7 7
Glaucoma 6 6
Corneal Decompensation 5 5
Not Applicable 5 5
Endophthalmitis 5 5
Pupillary Block 4 4
Vitrectomy 4 4
Insufficient Information 4 4
Retinal Detachment 3 3
No Information 3 3
Edema 2 2
Red Eye(s) 2 2
Eye Injury 2 2
Foreign Body Sensation in Eye 2 2
Corneal Clouding/Hazing 1 1
Hypopyon 1 1
Corneal Touch 1 1
Corneal Ulcer 1 1
Nausea 1 1
Uveitis 1 1
Loss of Vision 1 1
Capsular Bag Tear 1 1
Intraocular Pressure Decreased 1 1
Iritis 1 1
Irritation 1 1

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