TPLC - Total Product Life Cycle

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Device	forceps, ophthalmic
Regulation Description	Manual ophthalmic surgical instrument.
Product Code	HNR
Regulation Number	886.4350
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Open or Close	209	209
Break	75	75
Adverse Event Without Identified Device or Use Problem	62	62
Activation Problem	49	49
Activation Failure	9	9
Mechanical Jam	7	7
Fitting Problem	6	6
Device-Device Incompatibility	5	5
Noise, Audible	3	3
Sharp Edges	3	3
Component Missing	2	2
Material Twisted/Bent	2	2
Scratched Material	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Mechanical Problem	2	2
Contamination	2	2
Flaked	2	2
Material Fragmentation	2	2
Dull, Blunt	1	1
Structural Problem	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Damaged by Another Device	1	1
Mechanics Altered	1	1
Insufficient Device Problem Information	1	1
Physical Resistance/Sticking	1	1
Particulates	1	1
Product Quality Problem	1	1
Fracture	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	307	307
Insufficient Information	78	79
Retinal Tear	25	25
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	23	23
Retinal Detachment	20	20
Hemorrhage/Blood Loss/Bleeding	13	13
Eye Injury	6	6
Macular Edema	6	6
Visual Impairment	5	5
Vitreous Hemorrhage	4	4
Retinal Degeneration	4	4
Retinal Hemorrhage	4	4
Corneal Abrasion	3	3
Capsular Bag Tear	3	3
Irritability	3	3
Itching Sensation	3	3
Foreign Body In Patient	3	3
Red Eye(s)	3	3
Retinal Injury	2	2
Intraocular Pressure Increased	2	2
Optical Nerve Damage	2	2
Laceration(s)	1	1
Visual Disturbances	1	1
Corneal Edema	1	1
Blurred Vision	1	1
Unspecified Eye / Vision Problem	1	1
Headache	1	1
Inflammation	1	1
Loss of Vision	1	1
Eye Pain	1	1
Phototoxicity	1	1
Swelling/ Edema	1	1
Diplopia/Double Vision	1	1