TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Dull, Blunt	2685	2685
Fail-Safe Did Not Operate	410	410
Failure to Cut	150	150
Material Twisted/Bent	56	56
Adverse Event Without Identified Device or Use Problem	51	173
Particulates	51	51
Material Fragmentation	45	45
Fail-Safe Problem	45	45
Protective Measures Problem	42	42
Insufficient Information	18	18
Appropriate Term/Code Not Available	15	15
Defective Component	12	12
Defective Device	12	12
Material Protrusion/Extrusion	7	7
Tear, Rip or Hole in Device Packaging	7	7
Flaked	6	6
Packaging Problem	6	6
Sharp Edges	5	5
Break	4	4
Material Disintegration	4	4
Material Integrity Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Material Deformation	4	4
Degraded	4	4
Failure to Advance	3	3
Device Contamination with Chemical or Other Material	3	3
Mechanics Altered	3	3
Material Too Rigid or Stiff	3	3
Contamination /Decontamination Problem	3	3
Physical Resistance/Sticking	3	3
Fitting Problem	3	3
Component Missing	2	2
Use of Device Problem	2	2
Product Quality Problem	2	2
Material Too Soft/Flexible	2	2
Shipping Damage or Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Advance	1	1
Material Puncture/Hole	1	1
Difficult to Open or Remove Packaging Material	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Malposition of Device	1	1
Mechanical Problem	1	1
Naturally Worn	1	1
Difficult to Open or Close	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1970	1970
Insufficient Information	804	804
No Patient Involvement	276	276
No Known Impact Or Consequence To Patient	205	205
No Consequences Or Impact To Patient	158	158
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Foreign Body In Patient	34	34
Laceration(s)	34	34
Corneal Edema	19	19
Device Embedded In Tissue or Plaque	16	16
Capsular Bag Tear	16	16
Eye Injury	15	15
Inflammation	12	12
Endophthalmitis	10	10
Corneal Perforation	9	9
Eye Pain	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Uveitis	7	7
Corneal Abrasion	7	7
Hematoma	7	7
Vitritis	7	7
Needle Stick/Puncture	5	5
Hemorrhage/Bleeding	4	4
Intraocular Pressure Decreased	4	4
Prolapse	4	4
Discomfort	4	4
Conjunctivitis	3	3
Visual Impairment	3	3
No Code Available	3	3
Wound Dehiscence	3	3
Pain	2	2
Corneal Ulcer	2	2
Hypopyon	2	2
Fibrosis	2	2
Foreign Body Sensation in Eye	2	2
Unspecified Eye / Vision Problem	1	1
Injury	1	1
Visual Disturbances	1	1
Irritation	1	1
Itching Sensation	1	123
Fluid Discharge	1	1
Dry Eye(s)	1	1
Tissue Damage	1	1
Blurred Vision	1	1
Complaint, Ill-Defined	1	1
Bacterial Infection	1	123
Halo	1	1
Corneal Scar	1	1
Increased Sensitivity	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Aug-16-2024
2	Alcon Research LLC	II	May-30-2024
3	Bausch & Lomb Inc Irb	II	Aug-24-2019
4	Beaver Visitec	II	Apr-09-2019
5	Beaver Visitec	III	Apr-04-2019
6	Beaver Visitec International, Inc.	II	Jun-20-2024
7	Beaver Visitec International, Inc.	II	Jan-04-2024
8	Beaver Visitec International, Inc.	II	Jan-04-2024
9	Beaver Visitec International, Inc.	II	Jan-04-2023
10	Beaver Visitec International, Inc.	II	Nov-16-2021
11	International Science & Technology, LP, DBA Diamatrix Ltd.	II	May-20-2022