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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 43 43
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 34 34
Adverse Event Without Identified Device or Use Problem 19 19
Particulates 16 16
Break 12 12
Complete Blockage 11 11
Obstruction of Flow 10 10
Insufficient Information 7 7
Material Opacification 6 6
Material Separation 6 6
Fitting Problem 6 6
Detachment Of Device Component 4 4
Infusion or Flow Problem 4 4
Activation, Positioning or Separation Problem 4 4
Device Dislodged or Dislocated 4 4
Sharp Edges 4 4
Contamination /Decontamination Problem 4 4
Connection Problem 3 3
Activation Failure 3 3
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Activation Problem 3 3
Unintended Ejection 3 3
Device Handling Problem 3 3
Inadequate or Insufficient Training 3 3
Material Fragmentation 3 3
Device Contamination with Chemical or Other Material 3 3
Fracture 2 2
Unsealed Device Packaging 2 2
Material Twisted/Bent 2 2
Mechanical Problem 2 2
Difficult to Advance 2 2
Difficult to Insert 2 2
Loose or Intermittent Connection 1 1
Output above Specifications 1 1
Material Rupture 1 1
Device Displays Incorrect Message 1 1
Component Falling 1 1
Disconnection 1 1
Entrapment of Device 1 1
Scratched Material 1 1
Degraded 1 1
Blocked Connection 1 1
Device Difficult to Setup or Prepare 1 1
Device Slipped 1 1
Noise, Audible 1 1
No Flow 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Unexpected Shutdown 1 1
Difficult to Remove 1 1
Device Operates Differently Than Expected 1 1
Migration or Expulsion of Device 1 1
Device Fell 1 1
Defective Component 1 1
Device-Device Incompatibility 1 1
Corroded 1 1
Misconnection 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Accessory Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
No Consequences Or Impact To Patient 24 24
Capsular Bag Tear 22 22
Foreign Body In Patient 18 18
No Known Impact Or Consequence To Patient 17 17
Device Embedded In Tissue or Plaque 9 9
Eye Injury 7 7
Retinal Tear 6 6
Hemorrhage/Bleeding 5 5
Vitrectomy 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Retinal Injury 4 4
No Patient Involvement 4 4
Insufficient Information 3 3
Vitreous Hemorrhage 3 3
Corneal Abrasion 2 2
Tissue Damage 2 2
Endophthalmitis 2 2
No Code Available 2 2
Corneal Clouding/Hazing 2 2
Keratitis 2 2
Pain 1 1
Discomfort 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Hyphema 1 1
Zonular Dehiscence 1 1
Rupture 1 1
Corneal Perforation 1 1
Failure of Implant 1 1
Visual Disturbances 1 1
Vitreous Loss 1 1
Vitritis 1 1
Unspecified Tissue Injury 1 1
Edema 1 1
Loss of Vision 1 1
Corneal Edema 1 1
Inflammation 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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