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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
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 1335 1335
Fail-Safe Did Not Operate 410 410
Failure to Cut 142 142
Particulates 51 51
Material Twisted/Bent 48 48
Adverse Event Without Identified Device or Use Problem 47 169
Fail-Safe Problem 45 45
Material Fragmentation 42 42
Protective Measures Problem 42 42
Insufficient Information 17 17
Appropriate Term/Code Not Available 13 13
Defective Device 10 10
Tear, Rip or Hole in Device Packaging 7 7
Flaked 6 6
Material Protrusion/Extrusion 5 5
Packaging Problem 5 5
Sharp Edges 5 5
Material Deformation 4 4
Material Integrity Problem 4 4
Break 4 4
Degraded 4 4
Material Disintegration 4 4
Material Too Rigid or Stiff 3 3
Failure to Advance 3 3
Fitting Problem 3 3
Defective Component 3 3
Mechanics Altered 3 3
Device Contamination with Chemical or Other Material 3 3
Contamination /Decontamination Problem 3 3
Component Missing 2 2
Use of Device Problem 2 2
Physical Resistance/Sticking 2 2
Inadequacy of Device Shape and/or Size 1 1
Contamination 1 1
Mechanical Problem 1 1
Material Puncture/Hole 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Detachment of Device or Device Component 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Naturally Worn 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1252 1252
No Patient Involvement 276 276
No Known Impact Or Consequence To Patient 205 205
No Consequences Or Impact To Patient 158 158
Insufficient Information 154 154
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Foreign Body In Patient 34 34
Laceration(s) 29 29
Device Embedded In Tissue or Plaque 16 16
Corneal Edema 14 14
Inflammation 11 11
Endophthalmitis 10 10
Corneal Perforation 9 9
Capsular Bag Tear 9 9
Eye Injury 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Uveitis 7 7
Vitritis 7 7
Needle Stick/Puncture 5 5
Prolapse 4 4
Intraocular Pressure Decreased 4 4
Corneal Abrasion 4 4
Conjunctivitis 3 3
Hemorrhage/Bleeding 3 3
No Code Available 3 3
Fibrosis 2 2
Visual Impairment 2 2
Hypopyon 2 2
Foreign Body Sensation in Eye 2 2
Corneal Scar 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 123
Irritation 1 1
Itching Sensation 1 123
Blurred Vision 1 1
Tissue Damage 1 1
Visual Disturbances 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Fluid Discharge 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc Irb II Aug-24-2019
2 Beaver Visitec II Apr-09-2019
3 Beaver Visitec III Apr-04-2019
4 Beaver Visitec International, Inc. II Jan-04-2024
5 Beaver Visitec International, Inc. II Jan-04-2024
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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