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	3434	3435
Fail-Safe Did Not Operate	138	138
Failure to Cut	66	67
Material Twisted/Bent	66	66
Adverse Event Without Identified Device or Use Problem	60	60
Fail-Safe Problem	46	46
Protective Measures Problem	42	42
Particulates	39	39
Insufficient Device Problem Information	19	19
Inadequacy of Device Shape and/or Size	17	17
Material Protrusion/Extrusion	16	16
Material Fragmentation	16	16
Defective Component	15	17
Component Misassembled	14	14
Appropriate Device Problem Term/Code Not Available	14	14
Tear, Rip or Hole in Device Packaging	10	10
Defective Device	10	10
Packaging Problem	9	9
Device Damaged Prior to Receipt by User	8	8
Sharp Edges	6	6
Break	6	6
Product Quality Problem	3	5
Physical Resistance/Sticking	3	3
Material Too Rigid or Stiff	2	2
Unsealed Device Packaging	2	2
Material Deformation	2	2
Material Separation	2	2
Fitting Problem	2	2
Material Too Soft/Flexible	2	2
Disconnection	2	2
Contamination	1	1
Use of Device Problem	1	1
Positioning Problem	1	1
No Fail-Safe Mechanism	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Wrong Label	1	1
Material Puncture/Hole	1	1
Difficult to Open or Remove Packaging Material	1	1
Incomplete or Missing Packaging	1	1
Device Contamination with Chemical or Other Material	1	1
Mechanical Problem	1	1
Material Frayed	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2647	2649
Insufficient Information	1268	1268
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	57	57
Eye Injury	32	32
Corneal Edema	31	31
Inflammation	30	30
Laceration(s)	28	28
Wound Dehiscence	26	26
Foreign Body In Patient	24	24
Capsular Bag Tear	16	18
Prolapse	11	11
Eye Pain	10	10
Toxic Anterior Segment Syndrome (TASS)	10	10
Corneal Perforation	9	9
Corneal Abrasion	9	9
Eye Infections	8	8
Uveitis	7	7
Vitritis	7	7
Hematoma	7	7
Needle Stick/Puncture	6	6
Conjunctivitis	5	5
Endophthalmitis	5	5
Intraocular Pressure Decreased	5	5
Discomfort	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Bone Fracture(s)	4	4
Blurred Vision	4	4
Conjunctival Hemorrhage	4	4
Visual Impairment	3	3
Foreign Body Sensation in Eye	3	3
Corneal Ulcer	2	2
Pain	2	2
Red Eye(s)	2	2
Fibrosis	2	2
Hypopyon	2	2
Halo	2	2
Intraocular Pressure Increased	2	2
Eye Irritation	1	1
Itching Sensation	1	123
Irritation	1	1
Corneal Endothelial Cell Loss	1	1
Abrasion	1	1
Unspecified Eye / Vision Problem	1	1
Dry Eye(s)	1	1
Fluid Discharge	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Bacterial Infection	1	123
Hyperresponsive to stimuli	1	1
Corneal Scar	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	SSC- Surgical Specialties Corporation	II	Jun-04-2026
11	Tecfen Medical	II	Jun-11-2025