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	2742	2742
Fail-Safe Did Not Operate	410	410
Failure to Cut	98	98
Adverse Event Without Identified Device or Use Problem	57	179
Material Twisted/Bent	56	56
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
Material Protrusion/Extrusion	9	9
Defective Device	9	9
Tear, Rip or Hole in Device Packaging	9	9
Packaging Problem	7	7
Flaked	6	6
Shipping Damage or Problem	6	6
Break	5	5
Component Misassembled	5	5
Sharp Edges	5	5
Device Contamination with Chemical or Other Material	4	4
Inadequacy of Device Shape and/or Size	4	4
Material Deformation	4	4
Fitting Problem	3	3
Physical Resistance/Sticking	3	3
Failure to Advance	3	3
Material Too Rigid or Stiff	3	3
Material Too Soft/Flexible	2	2
Material Separation	2	2
Product Quality Problem	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
Mechanics Altered	1	1
Degraded	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	2113	2113
Insufficient Information	936	936
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	22	22
Capsular Bag Tear	15	15
Endophthalmitis	9	9
Corneal Perforation	9	9
Corneal Abrasion	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Eye Pain	8	8
Eye Infections	8	8
Hematoma	7	7
Uveitis	7	7
Vitritis	7	7
Needle Stick/Puncture	6	6
Prolapse	5	5
Intraocular Pressure Decreased	5	5
Discomfort	4	4
Hemorrhage/Bleeding	4	4
Conjunctivitis	3	3
Visual Impairment	3	3
Foreign Body Sensation in Eye	2	2
Hypopyon	2	2
Corneal Ulcer	2	2
Pain	2	2
Fibrosis	2	2
Increased Sensitivity	1	1
Device Embedded In Tissue or Plaque	1	1
Corneal Scar	1	1
Bacterial Infection	1	123
Blurred Vision	1	1
Unspecified Tissue Injury	1	1
Fluid Discharge	1	1
Unspecified Eye / Vision Problem	1	1
Visual Disturbances	1	1
Irritation	1	1
Itching Sensation	1	123
Dry Eye(s)	1	1
No Code Available	1	1
Halo	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