TPLC - Total Product Life Cycle

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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	124	124
Adverse Event Without Identified Device or Use Problem	17	17
Mechanical Problem	4	4
No Apparent Adverse Event	4	4
Ejection Problem	3	3
Material Deformation	3	3
Retraction Problem	2	2
Component Incompatible	2	2
Difficult to Insert	1	1
Difficult to Remove	1	1
Deformation Due to Compressive Stress	1	1
Failure to Eject	1	1
Break	1	1
Failure to Unfold or Unwrap	1	1
Difficult to Advance	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Material Split, Cut or Torn	1	1
Material Fragmentation	1	1
Device Dislodged or Dislocated	1	1
Patient Device Interaction Problem	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	133	133
No Clinical Signs, Symptoms or Conditions	25	25
Eye Injury	16	16
Pigment Dispersion Syndrome	7	7
Unspecified Eye / Vision Problem	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Hyphema	4	4
Capsular Bag Tear	3	3
Foreign Body In Patient	2	2
Pupillary Block	2	2
Inflammation	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Visual Disturbances	2	2
Corneal Edema	1	1
Prolapse	1	1
Intraocular Pressure Increased	1	1
Blurred Vision	1	1
Loss of Vision	1	1
Swelling/ Edema	1	1