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 Code	QCB
Regulation Number	886.3600
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025	2026
0	0	0	0	0	1	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequacy of Device Shape and/or Size	7959	8007
Adverse Event Without Identified Device or Use Problem	5177	5188
Off-Label Use	3138	3149
No Apparent Adverse Event	1760	1786
Device Dislodged or Dislocated	1418	1440
Misfocusing	1231	1249
Optical Problem	239	241
Unintended Movement	181	182
Patient-Device Incompatibility	164	168
Improper or Incorrect Procedure or Method	61	61
Patient Device Interaction Problem	13	13
Appropriate Term/Code Not Available	11	11
Insufficient Information	7	8
Particulates	6	6
Material Integrity Problem	5	5
Ejection Problem	5	5
Difficult to Fold, Unfold or Collapse	4	4
Material Opacification	3	3
Use of Device Problem	3	3
Product Quality Problem	3	3
Contamination	2	2
Compatibility Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination /Decontamination Problem	1	1
Scratched Material	1	1
Material Deformation	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	11675	11749
Blurred Vision	1862	1880
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1810	1828
No Code Available	846	846
Intraocular Pressure Increased	709	717
Visual Disturbances	373	375
Halo	308	309
Cataract	168	172
No Known Impact Or Consequence To Patient	121	121
Inflammation	104	104
Toxic Anterior Segment Syndrome (TASS)	96	96
Corneal Edema	76	76
Headache	57	57
Discomfort	57	60
No Consequences Or Impact To Patient	52	52
Pupillary Block	51	52
Eye Pain	36	36
Endophthalmitis	35	35
Uveitis	34	34
Pain	30	30
Iritis	27	27
No Patient Involvement	21	21
Glaucoma	17	17
Dry Eye(s)	13	13
Corneal Decompensation	12	12
Insufficient Information	10	10
Hyphema	9	9
Red Eye(s)	8	8
Visual Impairment	8	8
Vomiting	8	8
Retinal Detachment	7	8
Hypopyon	6	6
Swelling/ Edema	6	6
Nausea	5	5
Foreign Body Sensation in Eye	5	5
Capsular Bag Tear	4	4
Macular Edema	4	4
UGH (Uveitis Glaucoma Hyphema) Syndrome	4	4
Unspecified Eye / Vision Problem	3	3
Fatigue	3	3
Corneal Clouding/Hazing	3	3
Eye Injury	2	2
Dizziness	2	2
Vitrectomy	2	2
Irritation	1	1
Corneal Stromal Edema	1	1
Conjunctivitis	1	1
Hernia	1	1
Keratitis	1	1
Subluxation	1	1