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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 LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH AND LOMB
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 3
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
OERTLI INSTRUMENTE AG
  SUBSTANTIALLY EQUIVALENT 1
RAICO LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2287 2287
2020 1217 1217
2021 1673 1673
2022 1907 1907
2023 1803 1803
2024 1087 1089

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1005 1005
Failure to Cut 805 805
Appropriate Term/Code Not Available 741 741
Unexpected Shutdown 617 617
Failure to Deliver Energy 578 578
Suction Problem 557 557
Energy Output Problem 515 515
Overheating of Device 473 473
Decrease in Suction 436 436
Suction Failure 375 375
Particulates 339 339
Operating System Becomes Nonfunctional 338 338
Inability to Irrigate 253 253
Therapeutic or Diagnostic Output Failure 237 237
Pressure Problem 205 205
Loss of Power 180 180
Nonstandard Device 173 173
Complete Blockage 160 160
Break 152 152
Defective Device 146 146
Infusion or Flow Problem 121 121
No Flow 113 113
Power Problem 112 112
Noise, Audible 105 105
Defective Component 105 105
Output Problem 97 97
Insufficient Information 96 96
Obstruction of Flow 89 89
Leak/Splash 86 86
Fluid/Blood Leak 76 76
Application Program Freezes, Becomes Nonfunctional 76 76
Unsealed Device Packaging 74 74
Device Displays Incorrect Message 72 72
Decrease in Pressure 72 72
Failure to Prime 69 69
Mechanical Problem 65 65
Contamination 59 59
Gas Output Problem 58 58
Self-Activation or Keying 58 58
Material Fragmentation 57 57
Loose or Intermittent Connection 55 55
Improper Flow or Infusion 52 52
Electrical /Electronic Property Problem 51 51
Computer Operating System Problem 51 51
Failure to Power Up 49 49
Gas/Air Leak 49 49
Detachment of Device or Device Component 45 45
Excessive Heating 45 45
Intermittent Energy Output 44 44
Use of Device Problem 44 44
Contamination /Decontamination Problem 39 39
Insufficient Flow or Under Infusion 38 38
Reflux within Device 38 38
No Display/Image 37 37
No Device Output 36 36
Device Alarm System 35 35
Insufficient Heating 32 32
Failure to Fire 32 32
Display or Visual Feedback Problem 28 28
Material Twisted/Bent 27 27
Computer Software Problem 26 27
Failure to Infuse 24 24
Communication or Transmission Problem 23 23
Backflow 20 20
Connection Problem 20 20
Activation Problem 20 20
Increase in Pressure 19 19
Device Emits Odor 17 17
Output below Specifications 17 17
No Pressure 17 17
Temperature Problem 16 16
Firing Problem 16 16
Physical Resistance/Sticking 16 16
Environmental Compatibility Problem 16 16
Disconnection 15 15
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Smoking 14 14
Intermittent Loss of Power 14 14
Increase in Suction 13 13
Component Missing 12 12
Intermittent Continuity 12 12
Restricted Flow rate 12 12
Priming Problem 12 12
Mechanical Jam 12 12
Inappropriate or Unexpected Reset 12 12
Mechanics Altered 11 11
Excess Flow or Over-Infusion 11 11
Crack 11 11
Material Discolored 11 11
Use of Incorrect Control/Treatment Settings 10 10
Delivered as Unsterile Product 10 10
Blocked Connection 10 10
Vibration 10 10
Failure to Shut Off 10 10
Optical Problem 10 10
Activation, Positioning or Separation Problem 9 9
Material Deformation 9 9
Improper or Incorrect Procedure or Method 9 9
Unstable 9 9
Dull, Blunt 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4792 4794
No Known Impact Or Consequence To Patient 1237 1237
No Consequences Or Impact To Patient 1171 1171
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 506 506
Insufficient Information 496 496
Eye Burn 457 458
Capsular Bag Tear 369 369
Toxic Anterior Segment Syndrome (TASS) 228 228
Corneal Edema 211 211
No Patient Involvement 186 186
Endophthalmitis 127 127
No Code Available 110 110
Intraocular Pressure Decreased 108 108
Inflammation 99 99
Eye Injury 86 87
Blurred Vision 86 86
Visual Impairment 66 66
Vitrectomy 60 61
Intraocular Pressure Increased 58 58
Fibrosis 56 56
Eye Pain 49 49
Hypopyon 49 49
Uveitis 44 44
Burn, Thermal 39 39
Foreign Body In Patient 37 37
Hemorrhage/Bleeding 36 36
Rupture 33 33
Visual Disturbances 29 29
Retinal Detachment 29 29
Corneal Clouding/Hazing 29 29
Vitreous Loss 27 27
Conjunctivitis 25 25
Burn(s) 24 24
Loss of Vision 23 23
Retinal Tear 22 22
Prolapse 22 22
No Information 19 19
Corneal Abrasion 18 18
Fluid Discharge 17 17
Macular Edema 16 16
Vitreous Floaters 16 16
Corneal Scar 14 14
Intraocular Pressure, Delayed, Uncontrolled 14 14
Vitritis 13 13
Collapse 13 13
Unspecified Eye / Vision Problem 11 11
Swelling 11 11
Corneal Decompensation 11 11
Iritis 10 10
Purulent Discharge 8 8
Hyphema 8 8
Device Embedded In Tissue or Plaque 8 8
Swelling/ Edema 8 8
Eye Infections 7 7
Intraocular Infection 7 7
Unspecified Infection 7 7
Keratitis 7 7
Retinal Injury 7 7
Vitreous Hemorrhage 7 7
Pain 6 6
Bacterial Infection 6 6
Corneal Perforation 6 6
Suture Abrasion 6 6
Injury 6 6
Patient Problem/Medical Problem 5 5
Zonular Dehiscence 5 5
Phototoxicity 5 5
Clouding, Central Corneal 5 5
Laceration(s) 4 4
Corneal Ulcer 4 4
Edema 4 4
Wound Dehiscence 4 4
High Blood Pressure/ Hypertension 4 4
Glaucoma 4 4
Discomfort 4 4
Toxicity 4 4
Vitreous Detachment 4 4
Drug Resistant Bacterial Infection 4 5
Anxiety 3 3
Wrinkling 3 3
Red Eye(s) 3 3
Halo 2 2
Nausea 2 2
Irritation 2 2
Hematoma 2 2
Hyperemia 2 2
Failure of Implant 2 2
Capsular Contracture 2 2
Dry Eye(s) 2 2
Cusp Tear 2 2
Superficial (First Degree) Burn 2 2
Cerebral Edema 2 2
Blister 1 1
Tissue Breakdown 1 1
Chemical Exposure 1 1
Post Operative Wound Infection 1 1
Skin Tears 1 1
Deformity/ Disfigurement 1 1
Unspecified Tissue Injury 1 1
Cyclitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Apr-23-2020
2 Alcon Research, LLC II Oct-11-2023
3 Alcon Research, LTD. II Aug-16-2023
4 D.O.R.C. Dutch Opthalmic Research Center Intl B.V. II Mar-21-2024
5 Dutch Ophthalmic USA, Inc. II Aug-12-2021
6 Johnson & Johnson Surgical Vision Inc II May-04-2022
7 Johnson & Johnson Surgical Vision, Inc. II May-02-2024
8 Johnson & Johnson Surgical Vision, Inc. II Jul-28-2023
9 Johnson & Johnson Surgical Vision, Inc. II Jan-20-2023
10 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
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