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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, ophthalmic
Product CodeHNR
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2019 82 82
2020 135 135
2021 63 63
2022 58 58
2023 98 98
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 308 308
Adverse Event Without Identified Device or Use Problem 48 48
Break 29 29
Mechanical Jam 18 18
Physical Resistance/Sticking 16 16
Mechanical Problem 5 5
Fitting Problem 3 3
Appropriate Term/Code Not Available 3 3
Noise, Audible 3 3
Material Twisted/Bent 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Mechanics Altered 2 2
Detachment of Device or Device Component 2 2
Difficult to Open or Remove Packaging Material 2 2
Defective Component 2 2
Material Fragmentation 2 2
Defective Device 2 2
Device Fell 2 2
Activation Problem 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Difficult to Insert 1 1
Component Missing 1 1
Failure to Advance 1 1
Separation Failure 1 1
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Entrapment of Device 1 1
Unintended Ejection 1 1
Flaked 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Device Damaged by Another Device 1 1
Output Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 209 209
No Consequences Or Impact To Patient 92 92
No Known Impact Or Consequence To Patient 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
No Patient Involvement 21 21
Retinal Detachment 17 17
Retinal Tear 17 17
Hemorrhage/Bleeding 16 16
Insufficient Information 9 9
Macular Edema 4 4
Visual Impairment 4 4
Vitreous Hemorrhage 4 4
Irritability 3 3
Itching Sensation 3 3
Red Eye(s) 3 3
Foreign Body In Patient 3 3
Eye Injury 2 2
Intraocular Pressure Increased 1 1
Edema 1 1
Laceration(s) 1 1
Vitrectomy 1 1
Phototoxicity 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Tissue Damage 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vortex Surgical Inc. II Feb-01-2024
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