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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 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 3702 3702
2024 1225 1225

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 8694 8694
Off-Label Use 3350 3350
Device Dislodged or Dislocated 1612 1612
No Apparent Adverse Event 1450 1450
Misfocusing 1397 1397
Adverse Event Without Identified Device or Use Problem 1149 1149
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
Particulates 2 2
Optical Decentration 2 2
Contamination 2 2
Break 1 1
Contamination /Decontamination Problem 1 1
Failure to Unfold or Unwrap 1 1
Use of Device Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Mechanical Jam 1 1
Packaging Problem 1 1
Scratched Material 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9223 9223
No Code Available 1763 1763
Blurred Vision 1355 1355
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 912 912
Intraocular Pressure Increased 563 563
Visual Disturbances 285 285
No Known Impact Or Consequence To Patient 253 253
Halo 252 252
No Consequences Or Impact To Patient 113 113
Cataract 108 108
Corneal Edema 76 76
Inflammation 54 54
Headache 52 52
Pupillary Block 44 44
Pain 43 43
Toxic Anterior Segment Syndrome (TASS) 39 39
No Patient Involvement 39 39
Discomfort 36 36
Eye Pain 32 32
Glaucoma 18 18
Uveitis 14 14
Iritis 14 14
Corneal Decompensation 13 13
Endophthalmitis 13 13
Dry Eye(s) 10 10
Red Eye(s) 10 10
Insufficient Information 10 10
Retinal Detachment 7 7
Visual Impairment 7 7
Vomiting 7 7
Swelling/ Edema 6 6
Not Applicable 5 5
Foreign Body Sensation in Eye 5 5
Hyphema 4 4
Hypopyon 4 4
Vitrectomy 4 4
Capsular Bag Tear 3 3
No Information 3 3
Corneal Clouding/Hazing 3 3
Fatigue 3 3
Nausea 3 3
Dizziness 2 2
Edema 2 2
Macular Edema 2 2
Eye Injury 2 2
UGH (Uveitis Glaucoma Hyphema) Syndrome 2 2
Intraocular Pressure Decreased 1 1
Corneal Touch 1 1
Corneal Ulcer 1 1
Conjunctivitis 1 1
Vitreous Floaters 1 1
Hernia 1 1
Loss of Vision 1 1
Irritation 1 1
Keratitis 1 1

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