TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	72	72
Complete Blockage	38	38
Break	38	38
Adverse Event Without Identified Device or Use Problem	32	32
Fitting Problem	27	27
Particulates	27	27
Material Separation	22	22
Obstruction of Flow	21	21
Detachment Of Device Component	19	19
Insufficient Information	18	18
Device Contamination with Chemical or Other Material	12	12
Device Dislodged or Dislocated	12	12
Contamination /Decontamination Problem	9	9
Device Operates Differently Than Expected	8	8
Migration or Expulsion of Device	8	8
Material Fragmentation	6	6
Infusion or Flow Problem	6	6
Material Opacification	6	6
Material Protrusion/Extrusion	5	5
Disconnection	5	5
Material Twisted/Bent	5	5
Material Deformation	5	5
Sharp Edges	5	5
Component Falling	5	5
Activation, Positioning or Separation Problem	4	4
Connection Problem	4	4
Material Frayed	4	4
No Flow	4	4
Sticking	3	3
Activation Failure	3	3
Product Quality Problem	3	3
Inadequate or Insufficient Training	3	3
Blocked Connection	3	3
Loose or Intermittent Connection	3	3
Activation Problem	3	3
Maintenance Does Not Comply To Manufacturers Recommendations	3	3
Difficult to Advance	3	3
Inability to Irrigate	3	3
Device Handling Problem	3	3
Unsealed Device Packaging	3	3
Difficult to Insert	3	3
Device Slipped	3	3
Unintended Ejection	3	3
Mechanical Problem	2	2
Device Fell	2	2
Scratched Material	2	2
Component Missing	2	2
Partial Blockage	2	2
Extrusion	2	2
Fluid/Blood Leak	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	159	159
Capsular Bag Tear	43	43
No Consequences Or Impact To Patient	41	41
No Known Impact Or Consequence To Patient	36	36
Insufficient Information	26	26
Foreign Body In Patient	26	26
Hemorrhage/Bleeding	18	18
Eye Injury	12	12
No Information	12	12
Device Embedded In Tissue or Plaque	11	11
Vitrectomy	11	11
Retinal Tear	10	10
Vitreous Hemorrhage	8	8
Corneal Edema	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
No Code Available	6	6
Tissue Damage	5	5
Corneal Clouding/Hazing	4	4
No Patient Involvement	4	4
Injury	4	4
Retinal Injury	4	4
Keratitis	3	3
Zonular Dehiscence	3	3
Rupture	3	3
Inflammation	3	3
Endophthalmitis	3	3
Cataract	3	3
Vitreous Loss	3	3
Corneal Abrasion	2	2
Needle Stick/Puncture	2	2
Visual Disturbances	2	2
Intraocular Pressure, Delayed, Uncontrolled	2	2
Failure of Implant	2	2
Prolapse	2	2
Intraocular Pressure Increased	2	2
Erosion	1	1
Headache	1	1
Loss of Vision	1	1
Blurred Vision	1	1
Hyphema	1	1
Eye Pain	1	1
Corneal Perforation	1	1
Shock	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Fluid Discharge	1	1
Pain	1	1
Vitritis	1	1
Laceration(s)	1	1
Retinal Detachment	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Anodyne Surgical	II	Jun-11-2021
2	Bausch and Lomb, Incorporated	I	Jan-17-2013
3	Beaver Visitec	II	Mar-27-2019
4	Beaver Visitec International, Inc.	II	Mar-14-2024
5	Beaver-Visitec International Inc.	II	May-27-2014
6	Becton Dickinson and Company	II	May-10-2011
7	Dutch Ophthalmic USA, Inc.	II	Jul-19-2021
8	Ellex iScience, Inc.	II	Oct-01-2018
9	Ellex iScience, Inc.	II	Sep-04-2014
10	Hill-Rom, Inc.	II	Jun-19-2015
11	Insight Instruments, Inc.	II	May-10-2013
12	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
13	Synergetics Inc	II	Oct-22-2013
14	Vitreq Bv	II	Jan-24-2020