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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
Premarket Reviews
Manufacturer
Decision
ALCON RESEARCH, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
169
169
2015
401
401
2016
435
435
2017
472
472
2018
420
420
2019
291
291
2020
493
493
2021
403
403
2022
327
449
2023
353
353
2024
602
602
Device Problems
MDRs with this Device Problem
Events in those MDRs
Dull, Blunt
2940
2940
Failure to Cut
447
447
Fail-Safe Did Not Operate
410
410
Device Operates Differently Than Expected
103
103
Particulates
61
61
Adverse Event Without Identified Device or Use Problem
59
181
Material Twisted/Bent
54
54
Fail-Safe Problem
45
45
Material Fragmentation
45
45
Protective Measures Problem
44
44
Bent
33
33
Metal Shedding Debris
28
28
Material Integrity Problem
27
27
Insufficient Information
25
25
Product Quality Problem
22
22
Appropriate Term/Code Not Available
21
21
Material Deformation
20
20
Break
16
16
Mechanical Problem
15
15
Mechanics Altered
15
15
Defective Device
13
13
Device Contamination with Chemical or Other Material
10
10
Packaging Problem
8
8
Tear, Rip or Hole in Device Packaging
7
7
Defective Component
6
6
Material Protrusion/Extrusion
6
6
Flaked
6
6
Device Inoperable
6
6
Degraded
5
5
Malposition of Device
5
5
Sharp Edges
5
5
Component Missing
4
4
Failure to Advance
4
4
Scratched Material
4
4
Material Disintegration
4
4
Leak/Splash
4
4
Improper or Incorrect Procedure or Method
3
3
Fitting Problem
3
3
Material Too Rigid or Stiff
3
3
Naturally Worn
3
3
Physical Resistance
3
3
Contamination /Decontamination Problem
3
3
Detachment of Device or Device Component
3
3
Difficult to Advance
2
2
Out-Of-Box Failure
2
2
Physical Property Issue
2
2
Positioning Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Difficult to Open or Remove Packaging Material
2
2
Use of Device Problem
2
2
Difficult to Insert
2
2
Misassembled
2
2
Detachment Of Device Component
2
2
Contamination
2
2
Physical Resistance/Sticking
2
2
Material Too Soft/Flexible
1
1
Intermittent Continuity
1
1
Fracture
1
1
Nonstandard Device
1
1
Device Abrasion From Instrument Or Another Object
1
1
Air Leak
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Damaged Prior to Use
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Sticking
1
1
Device Stops Intermittently
1
1
Device Difficult to Setup or Prepare
1
1
Incorrect Software Programming Calculations
1
1
Material Puncture/Hole
1
1
Inadequate User Interface
1
1
Torn Material
1
1
Residue After Decontamination
1
1
Dent in Material
1
1
Difficult to Open or Close
1
1
Device Operational Issue
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1386
1386
No Known Impact Or Consequence To Patient
1105
1105
No Consequences Or Impact To Patient
942
942
No Patient Involvement
317
317
Insufficient Information
269
269
No Information
56
56
Foreign Body In Patient
55
55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
44
44
Laceration(s)
31
31
Device Embedded In Tissue or Plaque
26
26
No Code Available
25
25
Eye Injury
18
18
Corneal Edema
15
15
Injury
14
14
Capsular Bag Tear
13
13
Corneal Abrasion
13
13
Inflammation
13
13
Endophthalmitis
12
12
Corneal Perforation
9
9
Vitritis
8
8
Toxic Anterior Segment Syndrome (TASS)
8
8
Wound Dehiscence
7
7
Uveitis
7
7
Visual Impairment
6
6
Tissue Damage
6
6
Needle Stick/Puncture
5
5
Eye Pain
5
5
Intraocular Pressure Decreased
4
4
Prolapse
4
4
Hematoma
4
4
Hemorrhage/Bleeding
3
3
Pain
3
3
Conjunctivitis
3
3
Dry Eye(s)
3
3
Vitrectomy
3
3
Fluid Discharge
3
3
Discharge
2
2
Excessive Tear Production
2
2
Complaint, Ill-Defined
2
2
Fibrosis
2
2
Edema
2
2
Foreign Body Sensation in Eye
2
2
Headache
2
2
Failure to Anastomose
2
2
Abrasion
2
2
Blurred Vision
2
2
Hypopyon
2
2
Irritation
2
2
Itching Sensation
2
124
Iritis
1
1
Unspecified Infection
1
1
Red Eye(s)
1
1
Loss of Vision
1
1
Visual Disturbances
1
1
Vitreous Loss
1
1
Bacterial Infection
1
123
Cataract, Induced
1
1
Corneal Scar
1
1
Vitreous Floaters
1
1
Corneal Stromal Edema
1
1
Unspecified Eye / Vision Problem
1
1
Toxicity
1
1
Depression
1
1
Disability
1
1
Patient Problem/Medical Problem
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-04-2024
7
Beaver Visitec International, Inc.
II
Jan-04-2024
8
Beaver Visitec International, Inc.
II
Jan-04-2023
9
Beaver Visitec International, Inc.
II
Nov-16-2021
10
Becton Dickinson and Company
III
May-13-2010
11
International Science & Technology, LP, DBA Diamatrix Ltd.
II
May-20-2022
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