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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

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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