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	2870	2870
Fail-Safe Did Not Operate	411	411
Failure to Cut	99	99
Material Twisted/Bent	63	63
Adverse Event Without Identified Device or Use Problem	57	179
Particulates	51	51
Fail-Safe Problem	45	45
Protective Measures Problem	42	42
Material Fragmentation	26	26
Insufficient Information	18	18
Appropriate Term/Code Not Available	14	14
Defective Component	12	12
Defective Device	10	10
Material Protrusion/Extrusion	9	9
Tear, Rip or Hole in Device Packaging	9	9
Packaging Problem	8	8
Component Misassembled	7	7
Inadequacy of Device Shape and/or Size	7	7
Flaked	6	6
Shipping Damage or Problem	6	6
Break	5	5
Sharp Edges	5	5
Device Contamination with Chemical or Other Material	4	4
Material Deformation	4	4
Fitting Problem	3	3
Physical Resistance/Sticking	3	3
Failure to Advance	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
Material Disintegration	2	2
Difficult to Open or Remove Packaging Material	2	2
Degraded	1	1
Mechanics Altered	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Unsealed Device Packaging	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
Naturally Worn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2249	2249
Insufficient Information	991	991
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)	34	34
Corneal Edema	29	29
Foreign Body In Patient	28	28
Inflammation	27	27
Wound Dehiscence	25	25
Eye Injury	23	23
Capsular Bag Tear	16	16
Corneal Perforation	9	9
Endophthalmitis	9	9
Eye Pain	8	8
Corneal Abrasion	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Eye Infections	8	8
Uveitis	7	7
Hematoma	7	7
Vitritis	7	7
Needle Stick/Puncture	6	6
Intraocular Pressure Decreased	5	5
Prolapse	5	5
Hemorrhage/Bleeding	4	4
Discomfort	4	4
Conjunctivitis	3	3
Visual Impairment	3	3
Fibrosis	2	2
Pain	2	2
Corneal Ulcer	2	2
Hypopyon	2	2
Halo	2	2
Foreign Body Sensation in Eye	2	2
Unspecified Eye / Vision Problem	1	1
Irritation	1	1
Visual Disturbances	1	1
Fluid Discharge	1	1
Abrasion	1	1
Unspecified Tissue Injury	1	1
Blurred Vision	1	1
Itching Sensation	1	123
Dry Eye(s)	1	1
Bacterial Infection	1	123
No Code Available	1	1
Corneal Scar	1	1
Device Embedded In Tissue or Plaque	1	1
Increased Sensitivity	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	Tecfen Medical	II	Jun-11-2025