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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, ophthalmic
Product CodeHMX
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2019 27 27
2020 27 27
2021 41 41
2022 46 46
2023 93 93
2024 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 71 71
Complete Blockage 39 39
Particulates 28 28
Fitting Problem 26 26
Obstruction of Flow 25 25
Material Separation 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Break 14 14
Contamination /Decontamination Problem 9 9
Device Contamination with Chemical or Other Material 8 8
Insufficient Information 7 7
Material Opacification 6 6
Sharp Edges 5 5
Infusion or Flow Problem 5 5
Material Twisted/Bent 5 5
Material Protrusion/Extrusion 5 5
Material Frayed 4 4
Material Deformation 4 4
Activation, Positioning or Separation Problem 4 4
No Flow 4 4
Connection Problem 4 4
Fluid/Blood Leak 3 3
Activation Problem 3 3
Blocked Connection 3 3
Inadequate or Insufficient Training 3 3
Activation Failure 3 3
Partial Blockage 2 2
Unintended Ejection 2 2
Material Fragmentation 2 2
Device Dislodged or Dislocated 2 2
Defective Component 2 2
Device Fell 2 2
Inability to Irrigate 2 2
Disconnection 2 2
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Suction Problem 1 1
Corroded 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
Product Quality Problem 1 1
Noise, Audible 1 1
Device Handling Problem 1 1
Packaging Problem 1 1
Material Rupture 1 1
Misconnection 1 1
Device Difficult to Setup or Prepare 1 1
Backflow 1 1
Difficult to Insert 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 164 164
Insufficient Information 31 31
Capsular Bag Tear 28 28
Foreign Body In Patient 16 16
No Consequences Or Impact To Patient 16 16
Retinal Tear 10 10
Hemorrhage/Bleeding 9 9
No Known Impact Or Consequence To Patient 9 9
Device Embedded In Tissue or Plaque 9 9
Corneal Edema 8 8
Eye Injury 8 8
Vitreous Hemorrhage 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Corneal Clouding/Hazing 4 4
Keratitis 3 3
Zonular Dehiscence 3 3
Discomfort 3 3
Needle Stick/Puncture 2 2
Prolapse 2 2
Rupture 2 2
Tissue Damage 2 2
Visual Disturbances 2 2
Endophthalmitis 2 2
Intraocular Pressure Increased 2 2
Hyphema 2 2
Failure of Implant 2 2
Retinal Injury 2 2
Eye Pain 2 2
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
No Code Available 1 1
Inflammation 1 1
Corneal Perforation 1 1
Edema 1 1
Erosion 1 1
Cataract 1 1
Headache 1 1
Pain 1 1
Retinal Detachment 1 1
Shock 1 1
Vitreous Loss 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Vitritis 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Anodyne Surgical II Jun-11-2021
2 Beaver Visitec II Mar-27-2019
3 Beaver Visitec International, Inc. II Mar-14-2024
4 Dutch Ophthalmic USA, Inc. II Jul-19-2021
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Vitreq Bv II Jan-24-2020
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