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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 346 346

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 2694 2694
Failure to Cut 443 443
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 57 179
Material Twisted/Bent 53 53
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
Device Inoperable 6 6
Flaked 6 6
Material Protrusion/Extrusion 6 6
Sharp Edges 5 5
Malposition of Device 5 5
Defective Component 5 5
Degraded 5 5
Component Missing 4 4
Failure to Advance 4 4
Material Disintegration 4 4
Scratched Material 4 4
Leak/Splash 4 4
Fitting Problem 3 3
Material Too Rigid or Stiff 3 3
Detachment of Device or Device Component 3 3
Naturally Worn 3 3
Physical Resistance 3 3
Improper or Incorrect Procedure or Method 3 3
Contamination /Decontamination Problem 3 3
Misassembled 2 2
Physical Property Issue 2 2
Use of Device Problem 2 2
Contamination 2 2
Difficult to Open or Remove Packaging Material 2 2
Difficult to Insert 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Positioning Problem 2 2
Difficult to Advance 2 2
Out-Of-Box Failure 2 2
Physical Resistance/Sticking 2 2
Detachment Of Device Component 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Sticking 1 1
Inadequacy of Device Shape and/or Size 1 1
Dent in Material 1 1
Air Leak 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Inadequate User Interface 1 1
Nonstandard Device 1 1
Torn Material 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Stops Intermittently 1 1
Difficult to Remove 1 1
Device Operational Issue 1 1
Fracture 1 1
Incorrect Software Programming Calculations 1 1
Device Abrasion From Instrument Or Another Object 1 1
Difficult to Open or Close 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Intermittent Continuity 1 1
Residue After Decontamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1252 1252
No Known Impact Or Consequence To Patient 1105 1105
No Consequences Or Impact To Patient 942 942
No Patient Involvement 317 317
Insufficient Information 155 155
No Information 56 56
Foreign Body In Patient 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Laceration(s) 31 31
Device Embedded In Tissue or Plaque 26 26
No Code Available 25 25
Eye Injury 17 17
Corneal Edema 15 15
Injury 14 14
Inflammation 13 13
Endophthalmitis 12 12
Corneal Abrasion 11 11
Capsular Bag Tear 11 11
Corneal Perforation 9 9
Vitritis 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Uveitis 7 7
Wound Dehiscence 7 7
Tissue Damage 6 6
Visual Impairment 6 6
Needle Stick/Puncture 5 5
Prolapse 4 4
Intraocular Pressure Decreased 4 4
Vitrectomy 3 3
Fluid Discharge 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Conjunctivitis 3 3
Dry Eye(s) 3 3
Edema 2 2
Foreign Body Sensation in Eye 2 2
Headache 2 2
Failure to Anastomose 2 2
Abrasion 2 2
Irritation 2 2
Itching Sensation 2 124
Hypopyon 2 2
Blurred Vision 2 2
Fibrosis 2 2
Discharge 2 2
Excessive Tear Production 2 2
Complaint, Ill-Defined 2 2
Toxicity 1 1
Depression 1 1
Disability 1 1
Patient Problem/Medical Problem 1 1
Eye Pain 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Vitreous Loss 1 1
Unspecified Infection 1 1
Iritis 1 1
Red Eye(s) 1 1
Bacterial Infection 1 123
Cataract, Induced 1 1
Corneal Scar 1 1
Vitreous Floaters 1 1
Corneal Stromal Edema 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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