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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)
2021 2022 2023 2024 2025 2026
0 0 0 0 1 0

MDR Year MDR Reports MDR Events
2021 2887 2904
2022 2795 2823
2023 3703 3735
2024 3605 3619
2025 1398 1398
2026 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 6737 6783
Adverse Event Without Identified Device or Use Problem 4591 4601
Off-Label Use 2765 2776
No Apparent Adverse Event 1590 1616
Device Dislodged or Dislocated 1198 1219
Misfocusing 1043 1060
Optical Problem 208 210
Unintended Movement 166 167
Patient-Device Incompatibility 111 115
Improper or Incorrect Procedure or Method 43 43
Patient Device Interaction Problem 13 13
Appropriate Term/Code Not Available 10 10
Insufficient Information 6 7
Particulates 6 6
Ejection Problem 4 4
Difficult to Fold, Unfold or Collapse 3 3
Product Quality Problem 3 3
Material Integrity Problem 2 2
Contamination 2 2
Compatibility Problem 1 1
Material Opacification 1 1
Scratched Material 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Optical Decentration 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11016 11089
Blurred Vision 1563 1580
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1494 1511
Intraocular Pressure Increased 556 563
Visual Disturbances 298 300
Halo 262 263
Cataract 142 146
Toxic Anterior Segment Syndrome (TASS) 94 94
Inflammation 88 88
Corneal Edema 59 59
Pupillary Block 44 45
Discomfort 44 47
Headache 43 43
Eye Pain 31 31
Endophthalmitis 28 28
Uveitis 26 26
Pain 23 23
Iritis 22 22
Glaucoma 12 12
Dry Eye(s) 10 10
Corneal Decompensation 10 10
Hyphema 9 9
Visual Impairment 8 8
Retinal Detachment 7 8
Red Eye(s) 7 7
Insufficient Information 5 5
Swelling/ Edema 5 5
Hypopyon 5 5
Nausea 4 4
Macular Edema 4 4
UGH (Uveitis Glaucoma Hyphema) Syndrome 4 4
Fatigue 3 3
Corneal Clouding/Hazing 3 3
Foreign Body Sensation in Eye 3 3
Capsular Bag Tear 2 2
Dizziness 2 2
Keratitis 1 1
Conjunctivitis 1 1
Vomiting 1 1
Hernia 1 1
Subluxation 1 1
Vitreous Floaters 1 1

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