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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device knife, ophthalmic
Product CodeHNN
Regulation Number 886.4350
Device Class 1


Premarket Reviews
ManufacturerDecision
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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