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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
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 2021 2022 2023 2024
0 0 0 1 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2017 19 19
2018 10 10
2019 1102 1102
2020 1757 1757
2021 2887 2887
2022 2795 2795
2023 3703 3703
2024 2433 2433

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 8699 8699
Off-Label Use 3359 3359
Adverse Event Without Identified Device or Use Problem 2147 2147
No Apparent Adverse Event 1693 1693
Device Dislodged or Dislocated 1615 1615
Misfocusing 1398 1398
Optical Problem 273 273
Unintended Movement 193 193
Patient-Device Incompatibility 182 182
Improper or Incorrect Procedure or Method 65 65
Appropriate Term/Code Not Available 17 17
Patient Device Interaction Problem 14 14
Insufficient Information 10 10
Ejection Problem 9 9
Difficult to Fold, Unfold or Collapse 7 7
Material Opacification 5 5
Product Quality Problem 4 4
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Contamination 2 2
Particulates 2 2
Optical Decentration 2 2
Compatibility Problem 1 1
Break 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination /Decontamination Problem 1 1
Scratched Material 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Failure to Unfold or Unwrap 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10202 10202
No Code Available 1763 1763
Blurred Vision 1458 1458
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 969 969
Intraocular Pressure Increased 593 593
Visual Disturbances 302 302
Halo 274 274
No Known Impact Or Consequence To Patient 253 253
Cataract 116 116
No Consequences Or Impact To Patient 113 113
Corneal Edema 79 79
Inflammation 71 71
Toxic Anterior Segment Syndrome (TASS) 67 67
Headache 53 53
Pupillary Block 45 45
Pain 43 43
Discomfort 41 41
No Patient Involvement 39 39
Eye Pain 33 33
Glaucoma 18 18
Endophthalmitis 17 17
Uveitis 15 15
Iritis 15 15
Corneal Decompensation 13 13
Red Eye(s) 10 10
Dry Eye(s) 10 10
Insufficient Information 10 10
Retinal Detachment 8 8
Visual Impairment 7 7
Vomiting 7 7
Swelling/ Edema 6 6
Not Applicable 5 5
Hyphema 5 5
Foreign Body Sensation in Eye 5 5
Hypopyon 4 4
Vitrectomy 4 4
Capsular Bag Tear 3 3
No Information 3 3
Nausea 3 3
Fatigue 3 3
Macular Edema 3 3
Corneal Clouding/Hazing 3 3
Edema 2 2
Eye Injury 2 2
Dizziness 2 2
UGH (Uveitis Glaucoma Hyphema) Syndrome 2 2
Irritation 1 1
Keratitis 1 1
Corneal Ulcer 1 1
Conjunctivitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Staar Surgical Company II Dec-01-2023
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