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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 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 57 57
Particulates 26 26
Complete Blockage 25 25
Fitting Problem 23 23
Adverse Event Without Identified Device or Use Problem 17 17
Obstruction of Flow 16 16
Break 13 13
Material Separation 9 9
Contamination /Decontamination Problem 8 8
Device Contamination with Chemical or Other Material 8 8
Insufficient Information 7 7
Material Opacification 6 6
Infusion or Flow Problem 5 5
Material Deformation 4 4
Material Twisted/Bent 4 4
No Flow 4 4
Sharp Edges 4 4
Connection Problem 4 4
Activation, Positioning or Separation Problem 4 4
Blocked Connection 3 3
Inadequate or Insufficient Training 3 3
Activation Failure 3 3
Activation Problem 3 3
Device Dislodged or Dislocated 2 2
Device Fell 2 2
Defective Component 2 2
Partial Blockage 2 2
Unintended Ejection 2 2
Fluid/Blood Leak 2 2
Material Fragmentation 2 2
Inability to Irrigate 2 2
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Difficult to Insert 1 1
Accessory Incompatible 1 1
Backflow 1 1
Suction Problem 1 1
Device Slipped 1 1
Corroded 1 1
Degraded 1 1
Device Displays Incorrect Message 1 1
Difficult to Advance 1 1
Unexpected Shutdown 1 1
Suction Failure 1 1
Noise, Audible 1 1
Device Handling Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Scratched Material 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
Capsular Bag Tear 21 21
Foreign Body In Patient 16 16
No Consequences Or Impact To Patient 16 16
No Known Impact Or Consequence To Patient 9 9
Device Embedded In Tissue or Plaque 9 9
Retinal Tear 8 8
Insufficient Information 8 8
Eye Injury 7 7
Vitreous Hemorrhage 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Corneal Edema 5 5
Hemorrhage/Bleeding 5 5
Corneal Clouding/Hazing 4 4
Failure of Implant 2 2
Tissue Damage 2 2
Keratitis 2 2
Endophthalmitis 2 2
Retinal Injury 2 2
Visual Disturbances 2 2
Prolapse 2 2
Vitritis 1 1
Rupture 1 1
Discomfort 1 1
Injury 1 1
Needle Stick/Puncture 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Zonular Dehiscence 1 1
Pain 1 1
Retinal Detachment 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Shock 1 1
Inflammation 1 1
Intraocular Pressure Increased 1 1
Hyphema 1 1
Corneal Perforation 1 1
Edema 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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