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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 355 355
2024 1633 1633

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 2582 2582
Fail-Safe Did Not Operate 410 410
Failure to Cut 150 150
Material Twisted/Bent 52 52
Adverse Event Without Identified Device or Use Problem 51 173
Particulates 51 51
Fail-Safe Problem 45 45
Material Fragmentation 45 45
Protective Measures Problem 42 42
Insufficient Information 18 18
Appropriate Term/Code Not Available 15 15
Defective Device 12 12
Defective Component 11 11
Material Protrusion/Extrusion 7 7
Tear, Rip or Hole in Device Packaging 7 7
Flaked 6 6
Packaging Problem 6 6
Sharp Edges 5 5
Inadequacy of Device Shape and/or Size 4 4
Material Deformation 4 4
Degraded 4 4
Material Integrity Problem 4 4
Material Disintegration 4 4
Break 4 4
Contamination /Decontamination Problem 3 3
Material Too Rigid or Stiff 3 3
Mechanics Altered 3 3
Physical Resistance/Sticking 3 3
Device Contamination with Chemical or Other Material 3 3
Failure to Advance 3 3
Fitting Problem 3 3
Use of Device Problem 2 2
Component Missing 2 2
Product Quality Problem 2 2
Material Too Soft/Flexible 2 2
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Contamination 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Remove Packaging Material 1 1
Malposition of Device 1 1
Mechanical Problem 1 1
Naturally Worn 1 1
Difficult to Open or Close 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1918 1918
Insufficient Information 747 747
No Patient Involvement 276 276
No Known Impact Or Consequence To Patient 205 205
No Consequences Or Impact To Patient 158 158
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Foreign Body In Patient 34 34
Laceration(s) 34 34
Corneal Edema 19 19
Device Embedded In Tissue or Plaque 16 16
Capsular Bag Tear 15 15
Eye Injury 13 13
Inflammation 12 12
Endophthalmitis 10 10
Corneal Perforation 9 9
Eye Pain 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Uveitis 7 7
Corneal Abrasion 7 7
Hematoma 7 7
Vitritis 7 7
Needle Stick/Puncture 5 5
Hemorrhage/Bleeding 4 4
Intraocular Pressure Decreased 4 4
Prolapse 4 4
Discomfort 4 4
Visual Impairment 3 3
Conjunctivitis 3 3
No Code Available 3 3
Wound Dehiscence 3 3
Pain 2 2
Corneal Ulcer 2 2
Fibrosis 2 2
Hypopyon 2 2
Foreign Body Sensation in Eye 2 2
Unspecified Eye / Vision Problem 1 1
Injury 1 1
Visual Disturbances 1 1
Fluid Discharge 1 1
Irritation 1 1
Itching Sensation 1 123
Tissue Damage 1 1
Blurred Vision 1 1
Bacterial Infection 1 123
Complaint, Ill-Defined 1 1
Corneal Scar 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Aug-16-2024
2 Alcon Research LLC II May-30-2024
3 Bausch & Lomb Inc Irb II Aug-24-2019
4 Beaver Visitec II Apr-09-2019
5 Beaver Visitec III Apr-04-2019
6 Beaver Visitec International, Inc. II Jun-20-2024
7 Beaver Visitec International, Inc. II Jan-04-2024
8 Beaver Visitec International, Inc. II Jan-04-2024
9 Beaver Visitec International, Inc. II Jan-04-2023
10 Beaver Visitec International, Inc. II Nov-16-2021
11 International Science & Technology, LP, DBA Diamatrix Ltd. II May-20-2022
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