TPLC - Total Product Life Cycle

• Device: device, irrigation, ocular surgery
• Product Code: KYG
• Regulation Number: 886.4360
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	10	10
2019	13	13
2020	8	8
2021	19	19
2022	26	26

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	29	29
Break	17	17
Scratched Material	5	5
Material Twisted/Bent	4	4
Defective Device	4	4
Structural Problem	3	3
Disconnection	2	2
Material Fragmentation	2	2
Particulates	2	2
Material Puncture/Hole	1	1
Suction Problem	1	1
Defective Component	1	1
Dull, Blunt	1	1
Malposition of Device	1	1
Device Contamination with Chemical or Other Material	1	1
Infusion or Flow Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Crack	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Material Split, Cut or Torn	1	1
Sharp Edges	1	1
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Capsular Bag Tear	23	23
No Clinical Signs, Symptoms or Conditions	16	16
Toxic Anterior Segment Syndrome (TASS)	15	15
Uveitis	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
No Known Impact Or Consequence To Patient	7	7
Rupture	5	5
Vitritis	4	4
No Consequences Or Impact To Patient	4	4
Conjunctivitis	4	4
Inflammation	4	4
Endophthalmitis	3	3
Blurred Vision	3	3
Hypopyon	2	2
Corneal Edema	2	2
Insufficient Information	2	2
Excessive Tear Production	1	1
Fibrosis	1	1
No Information	1	1
No Code Available	1	1
Eye Pain	1	1
Unspecified Infection	1	1
Loss of Vision	1	1