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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, phacofragmentation
Product CodeHQC
Regulation Number 886.4670
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 4
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL)
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAICO LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2413 2413
2019 2287 2287
2020 1217 1217
2021 1673 1673
2022 1910 1910
2023 273 273

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 913 913
Failure to Cut 838 838
Appropriate Term/Code Not Available 604 604
Suction Problem 554 554
Unexpected Shutdown 460 460
Overheating of Device 445 445
Failure to Deliver Energy 365 365
Decrease in Suction 349 349
Energy Output Problem 345 345
Loss of Power 307 307
Particulates 288 288
Suction Failure 251 251
Defective Device 251 251
Operating System Becomes Nonfunctional 238 238
Therapeutic or Diagnostic Output Failure 238 238
Device Operates Differently Than Expected 216 216
Inability to Irrigate 203 203
Insufficient Information 176 176
Device Displays Incorrect Message 167 167
Power Problem 159 159
Pressure Problem 155 155
Break 152 152
Complete Blockage 136 136
Leak/Splash 127 127
Fluid/Blood Leak 119 119
Device Inoperable 114 114
Defective Component 112 112
Output Problem 111 111
Aspiration Issue 99 99
Obstruction of Flow 95 95
Noise, Audible 95 95
Unsealed Device Packaging 91 91
Mechanical Problem 90 90
Infusion or Flow Problem 86 86
Failure to Power Up 77 77
Application Program Freezes, Becomes Nonfunctional 68 68
Self-Activation or Keying 67 67
No Flow 66 66
Decrease in Pressure 63 63
Device Operational Issue 57 57
Detachment of Device or Device Component 57 57
Gas/Air Leak 56 56
Material Fragmentation 56 56
No Display/Image 52 52
Computer Operating System Problem 52 52
Electrical /Electronic Property Problem 51 51
No Device Output 45 45
Device Alarm System 44 44
Contamination /Decontamination Problem 42 42
Failure to Prime 39 39
Loose or Intermittent Connection 38 38
Computer Software Problem 36 36
Use of Device Problem 35 35
Contamination 33 33
Gas Output Problem 32 32
Occlusion Within Device 30 30
Improper Flow or Infusion 30 30
Intermittent Energy Output 30 30
Failure to Fire 29 29
Temperature Problem 28 28
Reflux within Device 28 28
Display or Visual Feedback Problem 27 27
Intermittent Continuity 25 25
Material Separation 23 23
Insufficient Flow or Under Infusion 23 23
Output below Specifications 23 23
Communication or Transmission Problem 22 22
Increase in Pressure 22 22
Insufficient Heating 21 21
Inappropriate or Unexpected Reset 21 21
Material Twisted/Bent 20 20
Activation Problem 20 20
Intermittent Loss of Power 20 20
No Pressure 19 19
Connection Problem 19 19
Device Emits Odor 19 19
Failure to Infuse 19 19
Smoking 19 19
Component Missing 18 18
Improper or Incorrect Procedure or Method 18 18
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Environmental Compatibility Problem 18 18
Device Contamination with Chemical or Other Material 17 17
Patient-Device Incompatibility 17 17
Backflow 17 17
Protective Measures Problem 16 16
Firing Problem 15 15
Physical Resistance/Sticking 15 15
Blocked Connection 15 15
Mechanical Jam 15 15
Partial Blockage 15 15
Air Leak 15 15
Use of Incorrect Control/Treatment Settings 15 15
Restricted Flow rate 15 15
Unstable 15 15
Mechanics Altered 14 14
Failure to Shut Off 14 14
Excessive Heating 13 13
Optical Problem 12 12
Material Deformation 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3055 3055
No Known Impact Or Consequence To Patient 2481 2481
No Consequences Or Impact To Patient 1679 1679
Eye Burn 400 401
Capsular Bag Tear 394 394
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 330 330
No Patient Involvement 294 294
Insufficient Information 193 193
No Code Available 184 184
Toxic Anterior Segment Syndrome (TASS) 176 176
Corneal Edema 173 173
Vitrectomy 117 118
Endophthalmitis 115 115
Inflammation 99 99
Eye Injury 86 87
No Information 73 73
Intraocular Pressure Decreased 69 69
Burn, Thermal 61 61
Foreign Body In Patient 58 58
Intraocular Pressure Increased 45 45
Uveitis 44 44
Visual Impairment 43 43
Hemorrhage/Bleeding 36 36
Intraocular Pressure, Delayed, Uncontrolled 34 34
Rupture 32 34
Hypopyon 31 31
Macular Edema 30 30
Blurred Vision 28 28
Retinal Detachment 28 28
Loss of Vision 25 25
Retinal Tear 22 22
Device Embedded In Tissue or Plaque 21 21
Vitreous Loss 19 19
Collapse 18 18
Eye Pain 18 18
Conjunctivitis 15 15
Vitreous Floaters 14 14
Vitritis 13 13
Swelling 12 12
Edema 12 12
Toxicity 12 12
Prolapse 11 11
Visual Disturbances 11 11
Unspecified Infection 9 9
Corneal Clouding/Hazing 9 9
Burn(s) 9 9
Keratitis 8 8
Suture Abrasion 8 8
Injury 8 8
Patient Problem/Medical Problem 7 7
Swelling/ Edema 7 7
Unspecified Eye / Vision Problem 7 7
Retinal Injury 7 7
Pain 7 7
Corneal Decompensation 7 7
Corneal Scar 7 7
Corneal Perforation 5 5
Corneal Abrasion 5 5
Intraocular Infection 5 5
Iritis 5 5
Zonular Dehiscence 5 5
Discomfort 5 5
Clouding, Central Corneal 5 5
Complaint, Ill-Defined 4 4
Vitreous Detachment 4 4
Fluid Discharge 4 4
Drug Resistant Bacterial Infection 4 5
Vitreous Hemorrhage 4 4
Phototoxicity 4 4
High Blood Pressure/ Hypertension 4 4
Corneal Ulcer 4 4
Purulent Discharge 3 3
Failure of Implant 3 3
Occlusion 3 3
Laceration(s) 3 3
Fibrosis 3 3
Wrinkling 3 3
Anxiety 3 3
Reaction 3 3
Excessive Tear Production 3 3
Superficial (First Degree) Burn 2 2
Eye Infections 2 2
Irritation 2 2
Perforation 2 2
Halo 2 2
Tissue Damage 2 2
Toxic Shock Syndrome 2 2
Hyphema 2 2
Hyperemia 2 2
Hematoma 2 2
Bacterial Infection 2 2
Capsular Contracture 2 2
Cataract 2 2
Chemosis 1 1
Adhesion(s) 1 1
Aspiration/Inhalation 1 1
Dry Eye(s) 1 1
Cyclitis 1 1
Glaucoma 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Apr-23-2020
2 Alcon Research, LTD. II Feb-28-2018
3 Dutch Ophthalmic USA, Inc. II Aug-12-2021
4 Johnson & Johnson Surgical Vision Inc II May-04-2022
5 Johnson & Johnson Surgical Vision, Inc. II Jan-20-2023
6 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
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