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TPLC
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Device
knife, ophthalmic
Regulation Description
Manual ophthalmic surgical instrument.
Product Code
HNN
Regulation Number
886.4350
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
493
493
2021
403
403
2022
327
449
2023
355
355
2024
1844
1844
2025
338
338
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
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