TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	457	491
Failure to Eject	291	292
Failure to Advance	193	193
Break	183	198
Crack	182	244
Material Twisted/Bent	138	138
Defective Device	135	135
Scratched Material	119	119
Device Difficult to Setup or Prepare	87	89
Difficult to Advance	73	73
Contamination	65	70
Inaccurate Delivery	59	59
Defective Component	58	58
Failure to Deliver	54	54
Adverse Event Without Identified Device or Use Problem	52	52
Physical Resistance/Sticking	45	45
Mechanical Jam	40	40
Unintended Ejection	39	39
Material Split, Cut or Torn	39	40
Device Contamination with Chemical or Other Material	36	36
Appropriate Term/Code Not Available	35	35
Failure to Unfold or Unwrap	31	31
Activation, Positioning or Separation Problem	31	31
Failure to Fold	26	26
Material Fragmentation	25	26
Mechanical Problem	20	21
Positioning Problem	13	13
Therapeutic or Diagnostic Output Failure	12	12
Delivered as Unsterile Product	10	10
Device Dislodged or Dislocated	10	10
Use of Device Problem	10	10
Ejection Problem	10	11
Difficult to Fold, Unfold or Collapse	9	9
Malposition of Device	9	9
Material Deformation	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Entrapment of Device	7	7
Difficult to Insert	6	6
Product Quality Problem	5	5
Material Opacification	5	5
Device Contaminated During Manufacture or Shipping	5	5
Material Too Rigid or Stiff	4	4
Premature Activation	4	4
Unintended Movement	4	4
Device Markings/Labelling Problem	4	4
Positioning Failure	3	3
Material Discolored	3	3
Detachment of Device or Device Component	3	3
Device Damaged Prior to Use	3	3
Misfire	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1047	1070
Insufficient Information	636	649
No Known Impact Or Consequence To Patient	111	132
No Consequences Or Impact To Patient	90	149
Capsular Bag Tear	52	52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	47	49
Eye Injury	34	34
Corneal Edema	27	27
No Code Available	23	23
Blurred Vision	19	19
Eye Pain	14	14
Visual Impairment	13	13
Visual Disturbances	12	12
Failure of Implant	11	11
Inflammation	11	11
Endophthalmitis	8	8
No Patient Involvement	7	7
Intraocular Pressure Increased	5	5
Fibrosis	5	5
Zonular Dehiscence	5	5
Uveitis	4	4
Hemorrhage/Bleeding	4	4
Foreign Body In Patient	4	4
Discomfort	4	4
Headache	3	3
Hypopyon	3	3
Rupture	3	3
Prolapse	3	3
Conjunctivitis	3	3
Hyperemia	2	2
Vitreous Floaters	2	2
Tissue Damage	2	2
Injury	2	2
Corneal Abrasion	2	2
Unspecified Infection	2	2
Viral Infection	1	1
Vomiting	1	1
Swelling	1	1
Retinal Detachment	1	1
Glaucoma	1	1
Pain	1	1
Blood Loss	1	1
Vitreous Hemorrhage	1	1
Dry Eye(s)	1	1
Swelling/ Edema	1	1
Toxic Anterior Segment Syndrome (TASS)	1	1
Corneal Decompensation	1	1
Organ Dehiscence	1	1
Hyphema	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Jan-10-2025