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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 329 451
2023 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 1133 1133
Fail-Safe Did Not Operate 401 401
Failure to Cut 175 175
Adverse Event Without Identified Device or Use Problem 45 167
Material Fragmentation 41 41
Material Twisted/Bent 38 38
Fail-Safe Problem 33 33
Particulates 31 31
Protective Measures Problem 21 21
Insufficient Information 17 17
Material Integrity Problem 10 10
Defective Device 10 10
Bent 7 7
Flaked 6 6
Tear, Rip or Hole in Device Packaging 6 6
Appropriate Term/Code Not Available 6 6
Sharp Edges 5 5
Device Contamination with Chemical or Other Material 5 5
Packaging Problem 5 5
Metal Shedding Debris 5 5
Device Operates Differently Than Expected 5 5
Break 5 5
Degraded 5 5
Material Disintegration 4 4
Failure to Advance 4 4
Material Protrusion/Extrusion 4 4
Material Deformation 4 4
Mechanics Altered 3 3
Fitting Problem 3 3
Contamination /Decontamination Problem 3 3
Material Too Rigid or Stiff 3 3
Mechanical Problem 2 2
Contamination 2 2
Detachment of Device or Device Component 2 2
Malposition of Device 2 2
Defective Component 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
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 766 766
No Known Impact Or Consequence To Patient 488 488
No Patient Involvement 281 281
No Consequences Or Impact To Patient 266 266
Insufficient Information 35 35
Foreign Body In Patient 30 30
Laceration(s) 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Device Embedded In Tissue or Plaque 17 17
Capsular Bag Tear 10 10
Eye Injury 10 10
Inflammation 10 10
No Code Available 9 9
Toxic Anterior Segment Syndrome (TASS) 8 8
Endophthalmitis 8 8
Uveitis 7 7
Vitritis 7 7
Needle Stick/Puncture 5 5
Conjunctivitis 3 3
Edema 2 2
Corneal Edema 2 2
Hypopyon 2 2
Tissue Damage 2 2
Prolapse 2 2
Fibrosis 2 2
No Information 2 2
Vitrectomy 1 1
Fluid Discharge 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Visual Disturbances 1 1
Pain 1 1
Irritation 1 1
Itching Sensation 1 123
Foreign Body Sensation in Eye 1 1
Headache 1 1
Dry Eye(s) 1 1
Corneal Abrasion 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 123
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-04-2023
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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