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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
2014 21 21
2015 9 9
2016 14 14
2017 18 18
2018 39 39
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 325 325
Break 54 54
Adverse Event Without Identified Device or Use Problem 51 51
Mechanical Jam 23 23
Physical Resistance/Sticking 20 20
Material Fragmentation 15 15
Particulates 7 7
Mechanical Problem 7 7
Device Dislodged or Dislocated 6 6
Sticking 5 5
Defective Device 5 5
Device Operates Differently Than Expected 4 4
Positioning Problem 4 4
Appropriate Term/Code Not Available 4 4
Device Handling Problem 4 4
Noise, Audible 3 3
Mechanics Altered 3 3
Detachment of Device or Device Component 3 3
Fitting Problem 3 3
Defective Component 2 2
Component Missing 2 2
Difficult to Open or Remove Packaging Material 2 2
Material Separation 2 2
Detachment Of Device Component 2 2
Entrapment of Device 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Device Fell 2 2
Activation Problem 1 1
Insufficient Information 1 1
Scratched Material 1 1
Output Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Integrity Problem 1 1
Unintended Ejection 1 1
Flaked 1 1
Fracture 1 1
Deflation Problem 1 1
Difficult to Insert 1 1
Inadequate Service 1 1
Misconnection 1 1
Device Difficult to Setup or Prepare 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Device Inoperable 1 1
Metal Shedding Debris 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Failure to Advance 1 1
Separation Failure 1 1
Folded 1 1
Connection Problem 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 209 209
No Consequences Or Impact To Patient 127 127
No Known Impact Or Consequence To Patient 96 96
No Patient Involvement 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Retinal Tear 18 18
Retinal Detachment 17 17
Hemorrhage/Bleeding 16 16
Eye Injury 11 11
Insufficient Information 9 9
Device Embedded In Tissue or Plaque 6 6
Foreign Body In Patient 6 6
Capsular Bag Tear 5 5
Vitrectomy 4 4
Visual Impairment 4 4
Vitreous Hemorrhage 4 4
Macular Edema 4 4
Itching Sensation 3 3
Red Eye(s) 3 3
Tissue Damage 3 3
Irritability 3 3
No Information 3 3
No Code Available 3 3
Loss of Vision 2 2
Visual Disturbances 1 1
Phototoxicity 1 1
Laceration(s) 1 1
Intraocular Infection 1 1
Intraocular Pressure Increased 1 1
Endophthalmitis 1 1
Cataract 1 1
Cataract, Induced 1 1
Edema 1 1
Sinus Perforation 1 1

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