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TPLC
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show TPLC since
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2024
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Device
knife, ophthalmic
Product Code
HNN
Regulation Number
886.4350
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
291
291
2020
493
493
2021
403
403
2022
327
449
2023
355
355
2024
1633
1633
Device Problems
MDRs with this Device Problem
Events in those MDRs
Dull, Blunt
2582
2582
Fail-Safe Did Not Operate
410
410
Failure to Cut
150
150
Material Twisted/Bent
52
52
Adverse Event Without Identified Device or Use Problem
51
173
Particulates
51
51
Fail-Safe Problem
45
45
Material Fragmentation
45
45
Protective Measures Problem
42
42
Insufficient Information
18
18
Appropriate Term/Code Not Available
15
15
Defective Device
12
12
Defective Component
11
11
Material Protrusion/Extrusion
7
7
Tear, Rip or Hole in Device Packaging
7
7
Flaked
6
6
Packaging Problem
6
6
Sharp Edges
5
5
Inadequacy of Device Shape and/or Size
4
4
Material Deformation
4
4
Degraded
4
4
Material Integrity Problem
4
4
Material Disintegration
4
4
Break
4
4
Contamination /Decontamination Problem
3
3
Material Too Rigid or Stiff
3
3
Mechanics Altered
3
3
Physical Resistance/Sticking
3
3
Device Contamination with Chemical or Other Material
3
3
Failure to Advance
3
3
Fitting Problem
3
3
Use of Device Problem
2
2
Component Missing
2
2
Product Quality Problem
2
2
Material Too Soft/Flexible
2
2
Shipping Damage or Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Contamination
1
1
Positioning Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Advance
1
1
Material Puncture/Hole
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Difficult to Open or Remove Packaging Material
1
1
Malposition of Device
1
1
Mechanical Problem
1
1
Naturally Worn
1
1
Difficult to Open or Close
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1918
1918
Insufficient Information
747
747
No Patient Involvement
276
276
No Known Impact Or Consequence To Patient
205
205
No Consequences Or Impact To Patient
158
158
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
49
49
Foreign Body In Patient
34
34
Laceration(s)
34
34
Corneal Edema
19
19
Device Embedded In Tissue or Plaque
16
16
Capsular Bag Tear
15
15
Eye Injury
13
13
Inflammation
12
12
Endophthalmitis
10
10
Corneal Perforation
9
9
Eye Pain
8
8
Toxic Anterior Segment Syndrome (TASS)
8
8
Uveitis
7
7
Corneal Abrasion
7
7
Hematoma
7
7
Vitritis
7
7
Needle Stick/Puncture
5
5
Hemorrhage/Bleeding
4
4
Intraocular Pressure Decreased
4
4
Prolapse
4
4
Discomfort
4
4
Visual Impairment
3
3
Conjunctivitis
3
3
No Code Available
3
3
Wound Dehiscence
3
3
Pain
2
2
Corneal Ulcer
2
2
Fibrosis
2
2
Hypopyon
2
2
Foreign Body Sensation in Eye
2
2
Unspecified Eye / Vision Problem
1
1
Injury
1
1
Visual Disturbances
1
1
Fluid Discharge
1
1
Irritation
1
1
Itching Sensation
1
123
Tissue Damage
1
1
Blurred Vision
1
1
Bacterial Infection
1
123
Complaint, Ill-Defined
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
Bausch & Lomb Inc Irb
II
Aug-24-2019
4
Beaver Visitec
II
Apr-09-2019
5
Beaver Visitec
III
Apr-04-2019
6
Beaver Visitec International, Inc.
II
Jun-20-2024
7
Beaver Visitec International, Inc.
II
Jan-04-2024
8
Beaver Visitec International, Inc.
II
Jan-04-2024
9
Beaver Visitec International, Inc.
II
Jan-04-2023
10
Beaver Visitec International, Inc.
II
Nov-16-2021
11
International Science & Technology, LP, DBA Diamatrix Ltd.
II
May-20-2022
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