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	403	437
Failure to Eject	291	291
Crack	176	236
Break	175	188
Failure to Advance	145	145
Defective Device	134	134
Scratched Material	115	115
Material Twisted/Bent	99	99
Difficult to Advance	69	69
Contamination	64	69
Device Difficult to Setup or Prepare	59	60
Defective Component	57	57
Adverse Event Without Identified Device or Use Problem	51	51
Inaccurate Delivery	47	47
Physical Resistance/Sticking	45	45
Mechanical Jam	39	39
Unintended Ejection	39	39
Material Split, Cut or Torn	38	38
Appropriate Term/Code Not Available	35	35
Device Contamination with Chemical or Other Material	35	35
Activation, Positioning or Separation Problem	31	31
Failure to Unfold or Unwrap	30	30
Failure to Deliver	30	30
Material Fragmentation	22	22
Failure to Fold	21	21
Mechanical Problem	20	20
Positioning Problem	13	13
Therapeutic or Diagnostic Output Failure	12	12
Device Dislodged or Dislocated	10	10
Delivered as Unsterile Product	10	10
Use of Device Problem	10	10
Malposition of Device	9	9
Difficult to Fold, Unfold or Collapse	9	9
Ejection Problem	9	10
Entrapment of Device	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Difficult to Insert	6	6
Material Deformation	5	5
Device Contaminated During Manufacture or Shipping	5	5
Material Opacification	5	5
Premature Activation	4	4
Material Too Rigid or Stiff	4	4
Product Quality Problem	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
Optical Decentration	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	924	942
Insufficient Information	568	581
No Known Impact Or Consequence To Patient	111	132
No Consequences Or Impact To Patient	90	149
Capsular Bag Tear	47	47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	46	47
Eye Injury	34	34
Corneal Edema	27	27
No Code Available	23	23
Blurred Vision	18	18
Eye Pain	12	12
Visual Disturbances	12	12
Failure of Implant	11	11
Visual Impairment	11	11
Inflammation	11	11
Endophthalmitis	8	8
No Patient Involvement	7	7
Fibrosis	5	5
Intraocular Pressure Increased	5	5
Zonular Dehiscence	4	4
Uveitis	4	4
Foreign Body In Patient	4	4
Discomfort	4	4
Hemorrhage/Bleeding	4	4
Rupture	3	3
Conjunctivitis	3	3
Headache	3	3
Prolapse	3	3
Hypopyon	3	3
Hyperemia	2	2
Injury	2	2
Unspecified Infection	2	2
Tissue Damage	2	2
Vitreous Floaters	2	2
Vitrectomy	1	1
Retinal Tear	1	1
Corneal Perforation	1	1
Loss of Vision	1	1
Therapeutic Effects, Unexpected	1	1
Corneal Clouding/Hazing	1	1
Organ Dehiscence	1	1
Hyphema	1	1
Swelling/ Edema	1	1
Vitreous Detachment	1	1
Vitreous Hemorrhage	1	1
Pain	1	1
Macular Edema	1	1
Viral Infection	1	1
Vomiting	1	1
Swelling	1	1

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