Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device cannula, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHMX
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2020 27 27
2021 41 42
2022 46 48
2023 93 93
2024 102 103
2025 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 79 79
Complete Blockage 68 69
Obstruction of Flow 40 40
Adverse Event Without Identified Device or Use Problem 37 37
Fitting Problem 35 35
Material Separation 34 34
Particulates 29 29
Break 14 15
Disconnection 8 8
Device Contamination with Chemical or Other Material 8 8
Insufficient Information 7 7
Contamination /Decontamination Problem 7 7
Material Opacification 6 6
Material Protrusion/Extrusion 5 5
Material Deformation 5 5
Sharp Edges 5 5
Infusion or Flow Problem 5 5
Material Frayed 4 4
No Flow 4 4
Activation, Positioning or Separation Problem 4 4
Material Fragmentation 4 4
Material Twisted/Bent 4 4
Fluid/Blood Leak 3 3
Inadequate or Insufficient Training 3 3
Activation Failure 3 3
Activation Problem 3 3
Defective Component 3 3
Blocked Connection 3 3
Connection Problem 2 2
Appropriate Term/Code Not Available 2 3
Product Quality Problem 2 2
Partial Blockage 2 2
Defective Device 2 2
Inability to Irrigate 2 2
Device Difficult to Setup or Prepare 1 1
Backflow 1 1
Difficult to Insert 1 1
Degraded 1 1
Scratched Material 1 1
Misconnection 1 1
Material Rupture 1 1
Device Fell 1 2
Packaging Problem 1 1
Difficult to Advance 1 1
Material Puncture/Hole 1 1
Material Disintegration 1 1
Suction Failure 1 1
Accessory Incompatible 1 1
No Apparent Adverse Event 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 224 227
Insufficient Information 64 64
Capsular Bag Tear 36 36
No Consequences Or Impact To Patient 14 14
Retinal Tear 13 13
Corneal Edema 12 12
Endophthalmitis 9 9
Eye Injury 9 9
Foreign Body In Patient 9 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Device Embedded In Tissue or Plaque 8 8
Hemorrhage/Bleeding 8 8
Inflammation 8 8
Blurred Vision 7 7
Vitreous Hemorrhage 7 7
Corneal Clouding/Hazing 4 4
Eye Infections 4 4
Eye Pain 3 3
Prolapse 3 3
Discomfort 3 3
Retinal Injury 3 3
No Known Impact Or Consequence To Patient 3 3
Keratitis 3 3
Zonular Dehiscence 3 3
Toxic Anterior Segment Syndrome (TASS) 3 3
Intraocular Pressure Increased 3 3
Unspecified Infection 3 3
Visual Disturbances 2 2
Rupture 2 2
Hyphema 2 2
Intraocular Pressure Decreased 2 2
Failure of Implant 2 2
Hypersensitivity/Allergic reaction 2 2
Vitreous Loss 2 2
Needle Stick/Puncture 1 1
Retinal Detachment 1 1
Conjunctivitis 1 1
Vitritis 1 1
Pain 1 1
Edema 1 1
Cataract 1 1
Unspecified Tissue Injury 1 1
Red Eye(s) 1 1
Swelling/ Edema 1 1
Shock 1 1
Tissue Damage 1 1
No Code Available 1 1
Loss of Vision 1 1
Erosion 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Anodyne Surgical II Jun-11-2021
2 Beaver Visitec International, Inc. II Mar-14-2024
3 Dutch Ophthalmic USA, Inc. II Jul-19-2021
4 Iantrek Inc. II Oct-10-2025
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Vitreq Bv II Jan-24-2020
-
-