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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
2018 38 38
2019 27 27
2020 27 27
2021 41 41
2022 46 46
2023 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 59 59
Particulates 25 25
Adverse Event Without Identified Device or Use Problem 21 21
Fitting Problem 20 20
Complete Blockage 20 20
Break 14 14
Obstruction of Flow 14 14
Device Contamination with Chemical or Other Material 10 10
Contamination /Decontamination Problem 8 8
Material Separation 8 8
Insufficient Information 7 7
Material Opacification 6 6
Connection Problem 4 4
Activation, Positioning or Separation Problem 4 4
Detachment Of Device Component 4 4
Infusion or Flow Problem 4 4
Material Deformation 4 4
Sharp Edges 4 4
Device Dislodged or Dislocated 4 4
Activation Problem 3 3
Material Twisted/Bent 3 3
No Flow 3 3
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Blocked Connection 3 3
Device Handling Problem 3 3
Activation Failure 3 3
Unintended Ejection 3 3
Material Fragmentation 3 3
Inadequate or Insufficient Training 3 3
Unsealed Device Packaging 2 2
Defective Component 2 2
Difficult to Insert 2 2
Inability to Irrigate 2 2
Fracture 2 2
Mechanical Problem 2 2
Difficult to Advance 2 2
Device Fell 2 2
Unexpected Shutdown 1 1
Suction Failure 1 1
Device Operates Differently Than Expected 1 1
Device-Device Incompatibility 1 1
Noise, Audible 1 1
Output Problem 1 1
Packaging Problem 1 1
Scratched Material 1 1
No Apparent Adverse Event 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Loose or Intermittent Connection 1 1
Fluid/Blood Leak 1 1
Accessory Incompatible 1 1
Partial Blockage 1 1
Component Falling 1 1
Corroded 1 1
Degraded 1 1
Disconnection 1 1
Entrapment of Device 1 1
Device Displays Incorrect Message 1 1
Output above Specifications 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 126 126
No Consequences Or Impact To Patient 24 24
Capsular Bag Tear 24 24
Foreign Body In Patient 22 22
No Known Impact Or Consequence To Patient 17 17
Device Embedded In Tissue or Plaque 9 9
Eye Injury 8 8
Hemorrhage/Bleeding 7 7
Retinal Tear 7 7
Vitreous Hemorrhage 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Retinal Injury 4 4
Insufficient Information 4 4
Vitrectomy 4 4
No Patient Involvement 4 4
Corneal Clouding/Hazing 4 4
Corneal Edema 4 4
Corneal Abrasion 2 2
Endophthalmitis 2 2
Failure of Implant 2 2
Keratitis 2 2
Tissue Damage 2 2
No Code Available 2 2
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Zonular Dehiscence 1 1
Vitritis 1 1
Shock 1 1
Rupture 1 1
Discomfort 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Prolapse 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Vitreous Loss 1 1
Pain 1 1
Retinal Detachment 1 1
Inflammation 1 1
Corneal Perforation 1 1
Edema 1 1
Hyphema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Anodyne Surgical II Jun-11-2021
2 Beaver Visitec II Mar-27-2019
3 Dutch Ophthalmic USA, Inc. II Jul-19-2021
4 Ellex iScience, Inc. II Oct-01-2018
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Vitreq Bv II Jan-24-2020
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