TPLC - Total Product Life Cycle

• Device: clip, iris retractor
• Product Code: HOC
• Regulation Number: 886.4350
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	4	4
2020	4	4
2022	6	6
2023	9	9
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	3	3
Retraction Problem	3	3
Adverse Event Without Identified Device or Use Problem	2	2
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Patient Device Interaction Problem	1	1
Material Split, Cut or Torn	1	1
Failure to Eject	1	1
Firing Problem	1	1
Physical Resistance/Sticking	1	1
Failure to Unfold or Unwrap	1	1
Use of Device Problem	1	1
Defective Device	1	1
Difficult to Advance	1	1
Material Deformation	1	1
Material Twisted/Bent	1	1
Entrapment of Device	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8	8
No Known Impact Or Consequence To Patient	4	4
Eye Injury	3	3
Hemorrhage/Bleeding	1	1
Intraocular Pressure Increased	1	1
Tissue Damage	1	1
Loss of Vision	1	1
Capsular Bag Tear	1	1
Foreign Body In Patient	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Corneal Edema	1	1
Endophthalmitis	1	1