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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
A.R.C. LASER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 9 9
2016 10 10
2017 59 59
2018 309 309
2019 41 41
2020 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 90 90
Difficult to Insert 88 88
Probe 84 84
Device Operational Issue 72 72
Tip 59 59
Cannula 42 42
Device Operates Differently Than Expected 24 24
Sticking 21 21
Failure to Advance 21 21
Trocar 20 20
Physical Resistance/Sticking 13 13
Laser 11 11
Material Separation 10 10
Device Contamination with Chemical or Other Material 10 10
Material Integrity Problem 7 7
Detachment Of Device Component 6 6
Inadequacy of Device Shape and/or Size 6 6
Detachment of Device or Device Component 6 6
Mechanical Problem 6 6
Difficult to Remove 5 5
Particulates 5 5
Physical Property Issue 5 5
Positioning Problem 5 5
Entrapment of Device 5 5
Device Inoperable 4 4
Material Deformation 4 4
Defective Component 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Dislodged or Dislocated 4 4
Failure to Cut 4 4
Air Leak 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Noise, Audible 3 3
Power Problem 3 3
Device Displays Incorrect Message 3 3
Component Falling 2 2
Valve(s) 2 2
Break 2 2
Display or Visual Feedback Problem 2 2
Material Fragmentation 2 2
Defective Device 2 2
Obstruction of Flow 2 2
Structural Problem 2 2
Physical Resistance 2 2
Infusion or Flow Problem 2 2
Material Twisted/Bent 2 2
No Flow 2 2
Therapeutic or Diagnostic Output Failure 1 1
Mechanical Jam 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Activation, Positioning or SeparationProblem 1 1
Incorrect Measurement 1 1
Component Incompatible 1 1
Loss of or Failure to Bond 1 1
Tube 1 1
Cord 1 1
Cutter/Blade 1 1
Difficult To Position 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Material Too Rigid or Stiff 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Material Split, Cut or Torn 1 1
Shaft 1 1
Partial Blockage 1 1
Disconnection 1 1
Inability to Irrigate 1 1
Leak/Splash 1 1
Delivered as Unsterile Product 1 1
Energy Output Problem 1 1
Malposition of Device 1 1
Aspiration Issue 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Advance 1 1
Pressure Problem 1 1
Device Fell 1 1
Port 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 212 212
No Known Impact Or Consequence To Patient 175 175
No Patient Involvement 11 11
Intraocular Pressure, Delayed, Uncontrolled 10 10
No Information 8 8
Eye Injury 6 6
Device Embedded In Tissue or Plaque 5 5
No Code Available 4 4
Foreign Body In Patient 4 4
Hemorrhage/Bleeding 3 3
Retinal Detachment 3 3
Retinal Injury 3 3
Loss of Vision 2 2
Endophthalmitis 2 2
Foreign Body Sensation in Eye 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Intraocular Pressure Increased 1 1
Retinal Tear 1 1
Thrombus 1 1
Optical Tissue, Breakdown Of 1 1
Vitritis 1 1
Corneal Edema 1 1
Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc II Sep-27-2018
2 Synergetics Inc II Oct-18-2016
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