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TPLC
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show TPLC since
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Device
knife, ophthalmic
Product Code
HNN
Regulation Number
886.4350
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
420
420
2019
291
291
2020
493
493
2021
403
403
2022
327
449
2023
295
295
Device Problems
MDRs with this Device Problem
Events in those MDRs
Dull, Blunt
1297
1297
Fail-Safe Did Not Operate
410
410
Failure to Cut
189
189
Adverse Event Without Identified Device or Use Problem
49
171
Particulates
47
47
Material Twisted/Bent
46
46
Fail-Safe Problem
45
45
Protective Measures Problem
42
42
Material Fragmentation
41
41
Insufficient Information
19
19
Appropriate Term/Code Not Available
10
10
Material Integrity Problem
10
10
Defective Device
10
10
Bent
7
7
Break
7
7
Flaked
6
6
Tear, Rip or Hole in Device Packaging
6
6
Metal Shedding Debris
5
5
Device Operates Differently Than Expected
5
5
Degraded
5
5
Device Contamination with Chemical or Other Material
5
5
Sharp Edges
5
5
Packaging Problem
5
5
Material Deformation
5
5
Material Protrusion/Extrusion
4
4
Material Disintegration
4
4
Failure to Advance
4
4
Fitting Problem
3
3
Defective Component
3
3
Contamination /Decontamination Problem
3
3
Material Too Rigid or Stiff
3
3
Mechanics Altered
3
3
Mechanical Problem
2
2
Contamination
2
2
Detachment of Device or Device Component
2
2
Malposition of Device
2
2
Component Missing
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
1
1
Device Markings/Labelling Problem
1
1
Difficult to Advance
1
1
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
1
1
Fracture
1
1
Leak/Splash
1
1
Air Leak
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Inoperable
1
1
Product Quality Problem
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Naturally Worn
1
1
Inadequate User Interface
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Physical Property Issue
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
995
995
No Known Impact Or Consequence To Patient
488
488
No Patient Involvement
281
281
No Consequences Or Impact To Patient
266
266
Insufficient Information
36
36
Foreign Body In Patient
35
35
Laceration(s)
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Device Embedded In Tissue or Plaque
17
17
Inflammation
11
11
Endophthalmitis
11
11
Eye Injury
10
10
Corneal Edema
10
10
Capsular Bag Tear
10
10
No Code Available
9
9
Toxic Anterior Segment Syndrome (TASS)
8
8
Vitritis
7
7
Uveitis
7
7
Needle Stick/Puncture
5
5
Prolapse
4
4
Visual Impairment
3
3
Conjunctivitis
3
3
Intraocular Pressure Decreased
3
3
Fibrosis
2
2
No Information
2
2
Edema
2
2
Hypopyon
2
2
Tissue Damage
2
2
Complaint, Ill-Defined
1
1
Injury
1
1
Visual Disturbances
1
1
Blurred Vision
1
1
Vitrectomy
1
1
Patient Problem/Medical Problem
1
1
Fluid Discharge
1
1
Corneal Scar
1
1
Dry Eye(s)
1
1
Irritation
1
1
Itching Sensation
1
123
Pain
1
1
Corneal Abrasion
1
1
Wound Dehiscence
1
1
Bacterial Infection
1
123
Foreign Body Sensation in Eye
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bausch & Lomb Inc Irb
II
Aug-24-2019
2
Bausch & Lomb Inc Irb
II
Mar-05-2018
3
Beaver Visitec
II
Apr-09-2019
4
Beaver Visitec
III
Apr-04-2019
5
Beaver Visitec
II
Aug-09-2018
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
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