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
Product CodeHQE
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
VISIONCARE DEVICES, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 309 309
2019 41 41
2020 30 30
2021 32 32
2022 46 46
2023 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 146 146
Difficult to Insert 85 85
Device Operational Issue 72 72
Failure to Advance 22 22
Sticking 19 19
Physical Resistance/Sticking 14 14
Failure to Cut 13 13
Device Operates Differently Than Expected 12 12
Material Separation 10 10
Particulates 7 7
Defective Component 7 7
Detachment of Device or Device Component 7 7
Device Contamination with Chemical or Other Material 7 7
Material Deformation 6 6
Material Integrity Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Physical Property Issue 5 5
Mechanical Problem 5 5
Entrapment of Device 5 5
Fluid/Blood Leak 4 4
Inadequacy of Device Shape and/or Size 4 4
Energy Output Problem 4 4
Material Twisted/Bent 4 4
Contamination /Decontamination Problem 4 4
Connection Problem 4 4
Difficult to Remove 4 4
Noise, Audible 3 3
Positioning Problem 3 3
Power Problem 3 3
Display or Visual Feedback Problem 3 3
Break 3 3
Detachment Of Device Component 2 2
Air Leak 2 2
Material Fragmentation 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Device Inoperable 2 2
Mechanical Jam 2 2
No Flow 2 2
Structural Problem 2 2
Physical Resistance 2 2
Device Displays Incorrect Message 2 2
Device Dislodged or Dislocated 2 2
Infusion or Flow Problem 2 2
Device Fell 1 1
Suction Failure 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Activation, Positioning or Separation Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Fire 1 1
Defective Device 1 1
Material Split, Cut or Torn 1 1
Gas/Air Leak 1 1
Pressure Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Insufficient Flow or Under Infusion 1 1
Inaccurate Delivery 1 1
Device Damaged Prior to Use 1 1
Unsealed Device Packaging 1 1
Smoking 1 1
Failure to Power Up 1 1
Incorrect Measurement 1 1
Migration or Expulsion of Device 1 1
Inability to Irrigate 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Filling Problem 1 1
Component Incompatible 1 1
Crack 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 183 183
No Known Impact Or Consequence To Patient 149 149
No Clinical Signs, Symptoms or Conditions 109 109
Intraocular Pressure, Delayed, Uncontrolled 8 8
Hemorrhage/Bleeding 6 6
No Patient Involvement 6 6
Foreign Body In Patient 6 6
No Information 5 5
No Code Available 4 4
Device Embedded In Tissue or Plaque 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Eye Injury 4 4
Retinal Injury 3 3
Insufficient Information 3 3
Capsular Bag Tear 2 2
Loss of Vision 2 2
Retinal Detachment 2 2
Intraocular Pressure Increased 1 1
Foreign Body Sensation in Eye 1 1
Hematoma 1 1
Corneal Edema 1 1
Endophthalmitis 1 1
Retinal Degeneration 1 1
Retinal Tear 1 1
Thrombus 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Eye Burn 1 1
Vitritis 1 1
Intraocular Pressure Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc II Sep-27-2018
-
-