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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
2017 472 472
2018 420 420
2019 291 291
2020 493 493
2021 403 403
2022 170 170

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 1379 1379
Fail-Safe Did Not Operate 342 342
Failure to Cut 237 237
Material Fragmentation 42 42
Adverse Event Without Identified Device or Use Problem 39 39
Particulates 37 37
Material Twisted/Bent 36 36
Device Operates Differently Than Expected 34 34
Fail-Safe Problem 33 33
Metal Shedding Debris 20 20
Bent 17 17
Protective Measures Problem 17 17
Material Integrity Problem 14 14
Defective Device 9 9
Material Deformation 8 8
Device Contamination with Chemical or Other Material 7 7
Mechanics Altered 7 7
Break 7 7
Product Quality Problem 7 7
Appropriate Term/Code Not Available 6 6
Sharp Edges 5 5
Insufficient Information 5 5
Material Protrusion/Extrusion 5 5
Degraded 5 5
Flaked 5 5
Material Disintegration 4 4
Failure to Advance 4 4
Component Missing 3 3
Improper or Incorrect Procedure or Method 3 3
Material Too Rigid or Stiff 3 3
Mechanical Problem 3 3
Malposition of Device 3 3
Contamination /Decontamination Problem 3 3
Packaging Problem 3 3
Positioning Problem 2 2
Detachment of Device or Device Component 2 2
Naturally Worn 2 2
Difficult to Open or Remove Packaging Material 2 2
Leak/Splash 2 2
Contamination 2 2
Fitting Problem 2 2
Defective Component 2 2
Use of Device Problem 2 2
Air Leak 1 1
Out-Of-Box Failure 1 1
Residue After Decontamination 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Device Inoperable 1 1
Intermittent Continuity 1 1
Fracture 1 1
Device Abrasion From Instrument Or Another Object 1 1
Misassembled 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Incorrect Software Programming Calculations 1 1
Inadequate User Interface 1 1
Device Markings/Labelling Problem 1 1
Device Operational Issue 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Physical Property Issue 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 745 745
No Clinical Signs, Symptoms or Conditions 578 578
No Consequences Or Impact To Patient 425 425
No Patient Involvement 287 287
Foreign Body In Patient 40 40
Insufficient Information 35 35
Laceration(s) 28 28
Device Embedded In Tissue or Plaque 23 23
No Code Available 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Information 11 11
Inflammation 11 11
Eye Injury 9 9
Endophthalmitis 8 8
Capsular Bag Tear 8 8
Vitritis 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Uveitis 7 7
Injury 7 7
Tissue Damage 6 6
Needle Stick/Puncture 5 5
Conjunctivitis 3 3
Corneal Abrasion 2 2
Corneal Edema 2 2
Edema 2 2
Wound Dehiscence 2 2
Headache 2 2
Hypopyon 2 2
Pain 2 2
Vitrectomy 2 2
Fluid Discharge 2 2
Blurred Vision 2 2
Fibrosis 2 2
Visual Impairment 1 1
Visual Disturbances 1 1
Complaint, Ill-Defined 1 1
Patient Problem/Medical Problem 1 1
Iritis 1 1
Irritation 1 1
Vitreous Floaters 1 1
Abrasion 1 1
Dry Eye(s) 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 Nov-16-2021
7 International Science & Technology, LP, DBA Diamatrix Ltd. II May-20-2022
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