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	211	211
Break	71	71
Adverse Event Without Identified Device or Use Problem	61	61
Activation Problem	30	30
Activation Failure	7	7
Fitting Problem	6	6
Sharp Edges	3	3
Noise, Audible	3	3
Device-Device Incompatibility	2	2
Scratched Material	2	2
Material Fragmentation	2	2
Component Missing	2	2
Material Twisted/Bent	2	2
Appropriate Term/Code Not Available	2	2
Mechanical Jam	2	2
Entrapment of Device	1	1
Mechanical Problem	1	1
Physical Resistance/Sticking	1	1
Defective Device	1	2
Contamination	1	1
Difficult to Insert	1	1
Particulates	1	1
Structural Problem	1	1
Device Damaged by Another Device	1	1
Mechanics Altered	1	1
Detachment of Device or Device Component	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Connection Problem	1	1
Flaked	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	285	285
Insufficient Information	54	55
Retinal Tear	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Retinal Detachment	20	20
Hemorrhage/Bleeding	13	13
Macular Edema	5	5
Visual Impairment	5	5
Eye Injury	5	5
Retinal Degeneration	4	4
Vitreous Hemorrhage	4	4
Red Eye(s)	3	3
Corneal Abrasion	3	3
Itching Sensation	3	3
Foreign Body In Patient	3	3
Irritability	3	3
Intraocular Pressure Increased	2	2
Optical Nerve Damage	2	2
Retinal Injury	2	2
Capsular Bag Tear	2	2
Phototoxicity	1	1
Visual Disturbances	1	1
Unspecified Eye / Vision Problem	1	1
Laceration(s)	1	1
Blurred Vision	1	1
Loss of Vision	1	1
Eye Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Vortex Surgical Inc.	II	Feb-01-2024