TPLC - Total Product Life Cycle

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Device	folders and injectors, intraocular lens (iol)
Regulation Description	Intraocular lens guide.
Product Code	MSS
Regulation Number	886.4300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	561	561
Device Contamination with Chemical or Other Material	382	382
Adverse Event Without Identified Device or Use Problem	221	221
Crack	187	187
Material Split, Cut or Torn	109	109
Scratched Material	107	107
Defective Device	76	76
Failure to Eject	75	75
Break	74	74
Contamination /Decontamination Problem	52	52
Material Twisted/Bent	43	43
Defective Component	35	35
Contamination	29	29
Physical Resistance/Sticking	28	28
No Apparent Adverse Event	20	20
Difficult to Advance	19	19
Insufficient Information	19	19
Failure to Advance	18	18
Particulates	18	18
Appropriate Term/Code Not Available	17	17
Use of Device Problem	16	16
Material Fragmentation	15	15
Material Separation	10	10
Activation, Positioning or Separation Problem	8	8
Mechanical Problem	8	8
Device Difficult to Setup or Prepare	7	7
Inaccurate Delivery	6	6
Ejection Problem	6	6
Unintended Ejection	6	6
Mechanical Jam	5	5
Burst Container or Vessel	5	5
Material Deformation	5	5
Difficult to Remove	5	5
Improper or Incorrect Procedure or Method	4	4
Material Rupture	4	4
Difficult to Insert	4	4
Off-Label Use	3	3
Product Quality Problem	3	3
Device Handling Problem	3	3
Detachment of Device or Device Component	2	2
Failure to Deliver	2	2
Failure to Fold	2	2
Device Markings/Labelling Problem	2	2
Entrapment of Device	2	2
Fitting Problem	2	2
Material Too Rigid or Stiff	1	1
No Pressure	1	1
Stretched	1	1
Patient Device Interaction Problem	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	853	853
Insufficient Information	691	691
No Known Impact Or Consequence To Patient	124	124
No Consequences Or Impact To Patient	52	52
Capsular Bag Tear	49	49
No Code Available	48	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Foreign Body In Patient	27	27
Eye Injury	23	23
Visual Impairment	22	22
Corneal Edema	14	14
Vitrectomy	13	13
Toxic Anterior Segment Syndrome (TASS)	12	12
Endophthalmitis	9	9
Visual Disturbances	9	9
Blurred Vision	8	8
Vitreous Loss	7	7
Eye Pain	7	7
Foreign Body Sensation in Eye	6	6
Inflammation	6	6
Loss of Vision	5	5
Uveitis	4	4
Iritis	4	4
Failure of Implant	4	4
Vitreous Floaters	4	4
Swelling/ Edema	4	4
Hypopyon	3	3
Corneal Abrasion	3	3
No Information	3	3
Unspecified Eye / Vision Problem	3	3
Fibrosis	2	2
Hemorrhage/Bleeding	2	2
No Patient Involvement	2	2
Keratitis	2	2
Edema	2	2
Red Eye(s)	2	2
Halo	2	2
Intraocular Pressure Increased	2	2
Wound Dehiscence	2	2
Conjunctivitis	1	1
Discomfort	1	1
Injury	1	1
Zonular Dehiscence	1	1
Unspecified Tissue Injury	1	1
Corneal Touch	1	1
Hyphema	1	1
Corneal Decompensation	1	1
Macular Edema	1	1
Bacterial Infection	1	1
Corneal Perforation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Rayner Intraocular Lenses Limited	II	Apr-21-2020