TPLC - Total Product Life Cycle

show TPLC since

Device	clip, iris retractor
Regulation Description	Manual ophthalmic surgical instrument.
Product Code	HOC
Regulation Number	886.4350
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Fold, Unfold or Collapse	75	75
Adverse Event Without Identified Device or Use Problem	17	17
Material Deformation	5	5
Mechanical Problem	4	4
No Apparent Adverse Event	4	4
Ejection Problem	3	3
Retraction Problem	3	3
Defective Device	2	2
Component Incompatible	2	2
Material Split, Cut or Torn	1	1
Entrapment of Device	1	1
Failure to Eject	1	1
Material Invagination	1	1
Difficult to Advance	1	1
Unintended Movement	1	1
Defective Component	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Misassembled During Installation	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Material Twisted/Bent	1	1
Failure to Unfold or Unwrap	1	1
Device Contamination with Chemical or Other Material	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	85	85
No Clinical Signs, Symptoms or Conditions	22	22
Eye Injury	16	16
Unspecified Eye / Vision Problem	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hyphema	4	4
Inflammation	2	2
Capsular Bag Tear	2	2
Foreign Body In Patient	2	2
Visual Disturbances	2	2
Pupillary Block	2	2
Hemorrhage/Bleeding	2	2
Intraocular Pressure Increased	1	1
Prolapse	1	1
Swelling/ Edema	1	1
Corneal Edema	1	1
Blurred Vision	1	1
Loss of Vision	1	1