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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device knife, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNN
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2021 403 403
2022 327 450
2023 355 358
2024 1844 1844
2025 700 700
2026 167 167

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 3214 3215
Fail-Safe Did Not Operate 133 133
Failure to Cut 78 79
Material Twisted/Bent 65 65
Adverse Event Without Identified Device or Use Problem 62 184
Fail-Safe Problem 46 46
Protective Measures Problem 42 42
Particulates 39 39
Material Fragmentation 20 20
Insufficient Information 19 19
Inadequacy of Device Shape and/or Size 16 16
Component Misassembled 14 14
Appropriate Term/Code Not Available 13 13
Material Protrusion/Extrusion 12 12
Defective Component 11 13
Defective Device 11 11
Tear, Rip or Hole in Device Packaging 10 10
Packaging Problem 9 9
Shipping Damage or Problem 7 7
Break 6 6
Sharp Edges 5 5
Physical Resistance/Sticking 3 3
Material Too Rigid or Stiff 3 3
Product Quality Problem 3 5
Disconnection 2 2
Fitting Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Material Too Soft/Flexible 2 2
Unsealed Device Packaging 2 2
Material Deformation 2 2
Material Separation 2 2
Inadequate User Interface 1 1
Loose or Intermittent Connection 1 1
Flaked 1 1
Failure to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Mechanics Altered 1 1
Use of Device Problem 1 1
Degraded 1 1
Contamination 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Wrong Label 1 1
Material Puncture/Hole 1 1
Malposition of Device 1 1
Incomplete or Missing Packaging 1 1
Mechanical Problem 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2518 2520
Insufficient Information 1137 1137
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Corneal Edema 31 31
Eye Injury 30 30
Inflammation 30 30
Wound Dehiscence 26 26
Foreign Body In Patient 23 23
Laceration(s) 21 21
Capsular Bag Tear 16 18
Prolapse 11 11
Toxic Anterior Segment Syndrome (TASS) 10 10
Eye Pain 10 10
Corneal Abrasion 9 9
Corneal Perforation 9 9
Eye Infections 8 8
Hematoma 7 7
Vitritis 7 7
Uveitis 7 7
Needle Stick/Puncture 6 6
Endophthalmitis 5 5
Conjunctivitis 5 5
Intraocular Pressure Decreased 5 5
Discomfort 4 4
Hemorrhage/Bleeding 4 4
Visual Impairment 3 3
Foreign Body Sensation in Eye 3 3
Blurred Vision 3 3
Corneal Ulcer 2 2
Red Eye(s) 2 2
Hypopyon 2 2
Intraocular Pressure Increased 2 2
Pain 2 2
Halo 2 2
Fibrosis 2 2
Dry Eye(s) 1 1
Itching Sensation 1 123
Abrasion 1 1
Irritation 1 1
Unspecified Eye / Vision Problem 1 1
Fluid Discharge 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 123
Corneal Scar 1 1
Increased Sensitivity 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 Beaver Visitec International, Inc. II Jun-20-2024
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
9 MicroSurgical Technology Inc II Oct-29-2025
10 Tecfen Medical II Jun-11-2025
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