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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
2020 493 493
2021 403 403
2022 327 449
2023 355 355
2024 1844 1844
2025 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 2656 2656
Fail-Safe Did Not Operate 410 410
Failure to Cut 98 98
Material Twisted/Bent 56 56
Particulates 51 51
Adverse Event Without Identified Device or Use Problem 48 170
Fail-Safe Problem 45 45
Protective Measures Problem 42 42
Material Fragmentation 26 26
Insufficient Information 18 18
Appropriate Term/Code Not Available 14 14
Defective Component 12 12
Material Protrusion/Extrusion 9 9
Tear, Rip or Hole in Device Packaging 9 9
Defective Device 9 9
Packaging Problem 7 7
Flaked 6 6
Break 5 5
Component Misassembled 5 5
Sharp Edges 5 5
Inadequacy of Device Shape and/or Size 4 4
Material Deformation 4 4
Failure to Advance 3 3
Device Contamination with Chemical or Other Material 3 3
Material Too Rigid or Stiff 3 3
Physical Resistance/Sticking 3 3
Fitting Problem 3 3
Use of Device Problem 2 2
Component Missing 2 2
Shipping Damage or Problem 2 2
Product Quality Problem 2 2
Material Disintegration 2 2
Difficult to Open or Remove Packaging Material 2 2
Material Too Soft/Flexible 2 2
Degraded 1 1
Contamination /Decontamination Problem 1 1
Contamination 1 1
Mechanics Altered 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unsealed Device Packaging 1 1
Difficult to Advance 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Malposition of Device 1 1
Incomplete or Missing Packaging 1 1
Mechanical Problem 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2088 2088
Insufficient Information 870 870
No Patient Involvement 272 272
No Consequences Or Impact To Patient 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
No Known Impact Or Consequence To Patient 51 51
Laceration(s) 34 34
Foreign Body In Patient 28 28
Corneal Edema 27 27
Eye Injury 21 21
Inflammation 20 20
Capsular Bag Tear 15 15
Wound Dehiscence 14 14
Endophthalmitis 9 9
Corneal Perforation 9 9
Toxic Anterior Segment Syndrome (TASS) 8 8
Eye Pain 8 8
Eye Infections 8 8
Corneal Abrasion 7 7
Hematoma 7 7
Uveitis 7 7
Vitritis 7 7
Needle Stick/Puncture 6 6
Prolapse 5 5
Intraocular Pressure Decreased 5 5
Discomfort 4 4
Hemorrhage/Bleeding 4 4
Conjunctivitis 3 3
Visual Impairment 3 3
Foreign Body Sensation in Eye 2 2
Hypopyon 2 2
Corneal Ulcer 2 2
Pain 2 2
Fibrosis 2 2
Increased Sensitivity 1 1
Device Embedded In Tissue or Plaque 1 1
Corneal Scar 1 1
Bacterial Infection 1 123
Blurred Vision 1 1
Unspecified Tissue Injury 1 1
Fluid Discharge 1 1
Unspecified Eye / Vision Problem 1 1
Visual Disturbances 1 1
Irritation 1 1
Itching Sensation 1 123
Dry Eye(s) 1 1
No Code Available 1 1
Halo 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
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