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 instrument, vitreous aspiration and cutting, ac-powered
Regulation Description Vitreous aspiration and cutting instrument.
Product CodeHQE
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
VISIONCARE DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 32 32
2022 46 47
2023 108 109
2024 105 108
2025 341 341
2026 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 200 200
Fitting Problem 167 167
Adverse Event Without Identified Device or Use Problem 138 138
Suction Problem 59 60
Suction Failure 43 44
Defective Component 25 26
Break 19 19
Improper Flow or Infusion 18 18
Fluid/Blood Leak 10 11
Ambient Noise Problem 9 9
Difficult to Insert 8 8
Particulates 8 8
Detachment of Device or Device Component 6 6
Material Twisted/Bent 5 5
Complete Blockage 4 4
Energy Output Problem 4 4
Obstruction of Flow 4 4
Gas/Air Leak 4 4
Loose or Intermittent Connection 3 3
Defective Device 3 3
Contamination 3 4
Connection Problem 3 3
Material Deformation 3 3
Loss of or Failure to Bond 2 2
Inability to Irrigate 2 2
Contamination /Decontamination Problem 2 2
Appropriate Term/Code Not Available 2 2
Failure to Advance 2 2
Insufficient Flow or Under Infusion 2 2
Failure to Fire 2 2
Noise, Audible 1 1
Output below Specifications 1 1
Radiofrequency Interference (RFI) 1 1
Firing Problem 1 1
Overheating of Device 1 1
Component Incompatible 1 1
Retraction Problem 1 1
Device Handling Problem 1 1
Decrease in Pressure 1 1
Decrease in Suction 1 1
Use of Device Problem 1 1
Failure to Power Up 1 1
Material Fragmentation 1 2
Air/Gas in Device 1 1
Filling Problem 1 1
Crack 1 1
Device Alarm System 1 1
Accessory Incompatible 1 1
Activation Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 456 460
Insufficient Information 100 100
Eye Infections 44 44
Transmissible Spongiform Encephalopathy(TSE) 33 33
Endophthalmitis 26 26
Retinal Tear 26 26
Laceration(s) 9 9
Phototoxicity 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Inflammation 5 5
Loss of Vision 5 5
Foreign Body In Patient 4 4
Intraocular Pressure Increased 3 3
Eye Burn 3 4
Blurred Vision 3 3
Capsular Bag Tear 2 2
Retinal Detachment 2 2
Intraocular Pressure Decreased 2 2
Hemorrhage/Bleeding 2 2
Iritis 1 1
Cataract 1 1
Hematoma 1 1
Retinal Degeneration 1 1
Eye Injury 1 1
Vitreous Hemorrhage 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Oct-24-2025
-
-