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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
Product CodeHQE
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
A.R.C. LASER GMBH
  SUBSTANTIALLY EQUIVALENT 1
VISIONCARE DEVICES, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 59 59
2018 309 309
2019 41 41
2020 30 30
2021 32 32
2022 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 128 128
Difficult to Insert 91 91
Device Operational Issue 72 72
Failure to Advance 23 23
Device Operates Differently Than Expected 21 21
Sticking 21 21
Physical Resistance/Sticking 14 14
Failure to Cut 12 12
Device Contamination with Chemical or Other Material 10 10
Material Separation 10 10
Material Deformation 8 8
Detachment of Device or Device Component 8 8
Material Integrity Problem 7 7
Particulates 7 7
Defective Component 7 7
Mechanical Problem 6 6
Detachment Of Device Component 6 6
Entrapment of Device 5 5
Inadequacy of Device Shape and/or Size 5 5
Difficult to Remove 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Physical Property Issue 5 5
Positioning Problem 4 4
Material Twisted/Bent 4 4
Device Dislodged or Dislocated 4 4
Fluid/Blood Leak 4 4
Break 4 4
Display or Visual Feedback Problem 3 3
Air Leak 3 3
Device Inoperable 3 3
Contamination /Decontamination Problem 3 3
Power Problem 3 3
Insufficient Information 3 3
Noise, Audible 3 3
Infusion or Flow Problem 2 2
Mechanical Jam 2 2
No Flow 2 2
Connection Problem 2 2
Device Displays Incorrect Message 2 2
Physical Resistance 2 2
Obstruction of Flow 2 2
Structural Problem 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Energy Output Problem 2 2
Unsealed Device Packaging 1 1
Migration or Expulsion of Device 1 1
Inability to Irrigate 1 1
Incorrect Measurement 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Component Falling 1 1
Component Incompatible 1 1
Crack 1 1
Disconnection 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Insufficient Flow or Under Infusion 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Device Damaged Prior to Use 1 1
Material Too Rigid or Stiff 1 1
Smoking 1 1
Difficult To Position 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Failure to Fire 1 1
Malposition of Device 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Pressure Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 204 204
No Known Impact Or Consequence To Patient 173 173
No Clinical Signs, Symptoms or Conditions 68 68
Intraocular Pressure, Delayed, Uncontrolled 10 10
No Information 8 8
No Patient Involvement 7 7
Hemorrhage/Bleeding 7 7
Foreign Body In Patient 6 6
Eye Injury 6 6
No Code Available 5 5
Device Embedded In Tissue or Plaque 4 4
Insufficient Information 3 3
Retinal Detachment 3 3
Retinal Injury 3 3
Retinal Tear 2 2
Loss of Vision 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Intraocular Pressure Decreased 1 1
Vitritis 1 1
Thrombus 1 1
Optical Tissue, Breakdown Of 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Eye Burn 1 1
Capsular Bag Tear 1 1
Retinal Degeneration 1 1
Intraocular Pressure Increased 1 1
Foreign Body Sensation in Eye 1 1
Hematoma 1 1
Corneal Edema 1 1
Endophthalmitis 1 1

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