TPLC - Total Product Life Cycle

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Device	knife, ophthalmic
Regulation Description	Manual ophthalmic surgical instrument.
Product Code	HNN
Regulation Number	886.4350
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Dull, Blunt	3084	3084
Fail-Safe Did Not Operate	411	411
Failure to Cut	99	99
Material Twisted/Bent	65	65
Adverse Event Without Identified Device or Use Problem	61	183
Particulates	51	51
Fail-Safe Problem	45	45
Protective Measures Problem	42	42
Material Fragmentation	29	29
Insufficient Information	18	18
Appropriate Term/Code Not Available	14	14
Component Misassembled	13	13
Defective Component	12	12
Defective Device	11	11
Inadequacy of Device Shape and/or Size	11	11
Material Protrusion/Extrusion	10	10
Tear, Rip or Hole in Device Packaging	10	10
Packaging Problem	9	9
Break	7	7
Flaked	6	6
Shipping Damage or Problem	6	6
Sharp Edges	5	5
Fitting Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Material Deformation	4	4
Failure to Advance	3	3
Physical Resistance/Sticking	3	3
Product Quality Problem	3	3
Material Too Rigid or Stiff	3	3
Material Too Soft/Flexible	2	2
Material Separation	2	2
Component Missing	2	2
Use of Device Problem	2	2
Degraded	2	2
Contamination	2	2
Material Disintegration	2	2
Difficult to Open or Remove Packaging Material	2	2
Mechanics Altered	1	1
Contamination /Decontamination Problem	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Unsealed Device Packaging	1	1
Wrong Label	1	1
Difficult to Advance	1	1
Material Puncture/Hole	1	1
Detachment of Device or Device Component	1	1
Malposition of Device	1	1
Incomplete or Missing Packaging	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2402	2402
Insufficient Information	1067	1067
No Patient Involvement	272	272
No Consequences Or Impact To Patient	56	56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	55	55
No Known Impact Or Consequence To Patient	51	51
Laceration(s)	35	35
Corneal Edema	31	31
Foreign Body In Patient	31	31
Inflammation	29	29
Wound Dehiscence	26	26
Eye Injury	26	26
Capsular Bag Tear	16	16
Prolapse	11	11
Eye Pain	10	10
Corneal Abrasion	10	10
Toxic Anterior Segment Syndrome (TASS)	10	10
Corneal Perforation	9	9
Endophthalmitis	9	9
Eye Infections	8	8
Uveitis	7	7
Hematoma	7	7
Vitritis	7	7
Needle Stick/Puncture	6	6
Intraocular Pressure Decreased	5	5
Conjunctivitis	5	5
Hemorrhage/Bleeding	4	4
Discomfort	4	4
Blurred Vision	3	3
Visual Impairment	3	3
Fibrosis	2	2
Pain	2	2
Corneal Ulcer	2	2
Red Eye(s)	2	2
Hypopyon	2	2
Halo	2	2
Intraocular Pressure Increased	2	2
Foreign Body Sensation in Eye	2	2
Unspecified Eye / Vision Problem	1	1
Visual Disturbances	1	1
Irritation	1	1
Itching Sensation	1	123
Fluid Discharge	1	1
Abrasion	1	1
Unspecified Tissue Injury	1	1
Dry Eye(s)	1	1
No Code Available	1	1
Bacterial Infection	1	123
Corneal Scar	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Aug-16-2024
2	Alcon Research LLC	II	May-30-2024
3	Beaver Visitec International, Inc.	II	Jun-20-2024
4	Beaver Visitec International, Inc.	II	Jan-04-2024
5	Beaver Visitec International, Inc.	II	Jan-04-2024
6	Beaver Visitec International, Inc.	II	Jan-04-2023
7	Beaver Visitec International, Inc.	II	Nov-16-2021
8	International Science & Technology, LP, DBA Diamatrix Ltd.	II	May-20-2022
9	MicroSurgical Technology Inc	II	Oct-29-2025
10	Tecfen Medical	II	Jun-11-2025