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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 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 339 339
Adverse Event Without Identified Device or Use Problem 48 48
Break 36 36
Mechanical Jam 18 18
Physical Resistance/Sticking 16 16
Fitting Problem 5 5
Mechanical Problem 5 5
Activation Problem 4 4
Noise, Audible 3 3
Appropriate Term/Code Not Available 3 3
Difficult to Open or Remove Packaging Material 2 2
Device Fell 2 2
Defective Component 2 2
Defective Device 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Fragmentation 2 2
Material Twisted/Bent 2 2
Mechanics Altered 2 2
Detachment of Device or Device Component 2 2
Dull, Blunt 1 1
Flaked 1 1
Overheating of Device 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Advance 1 1
Fracture 1 1
Device Contamination with Chemical or Other Material 1 1
Retraction Problem 1 1
Device Handling Problem 1 1
Device Damaged by Another Device 1 1
Particulates 1 1
Component Missing 1 1
Device Difficult to Setup or Prepare 1 1
Unintended Ejection 1 1
Difficult to Insert 1 1
Difficult to Remove 1 1
Separation Failure 1 1
Output Problem 1 1
Entrapment of Device 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
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
Insufficient Information 19 19
Retinal Detachment 17 17
Retinal Tear 17 17
Hemorrhage/Bleeding 16 16
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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