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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
ABBOTT MEDICAL OPTICS INC
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH + LOMB
  SUBSTANTIALLY EQUIVALENT 2
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
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAICO LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3355 3355
2016 3374 3374
2017 2781 2781
2018 2415 2415
2019 2287 2287
2020 1217 1217
2021 1673 1673
2022 1907 1907
2023 1803 1803
2024 627 627

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2021 2021
Failure to Cut 1893 1893
Adverse Event Without Identified Device or Use Problem 1533 1533
Suction Problem 1067 1067
Device Displays Incorrect Message 1016 1016
Device Inoperable 949 949
Loss of Power 886 886
Aspiration Issue 836 836
Appropriate Term/Code Not Available 798 798
Overheating of Device 619 619
Unexpected Shutdown 605 605
Decrease in Suction 568 568
Failure to Deliver Energy 536 536
Energy Output Problem 504 504
Particulates 482 482
Insufficient Information 454 454
Inability to Irrigate 410 410
Operating System Becomes Nonfunctional 347 347
Suction Failure 339 339
Break 306 306
Complete Blockage 285 285
Pressure Problem 284 284
Difficult to Insert 280 280
Defective Device 265 265
Leak/Splash 261 261
Failure to Power Up 260 260
Power Problem 245 245
Occlusion Within Device 244 244
Therapeutic or Diagnostic Output Failure 239 239
Fluid/Blood Leak 206 206
Noise, Audible 198 198
Infusion or Flow Problem 176 176
Nonstandard Device 165 165
Mechanical Problem 157 157
No Flow 156 156
Device Stops Intermittently 155 155
No Display/Image 152 152
Defective Component 150 150
Self-Activation or Keying 146 146
Device Contamination with Chemical or Other Material 139 139
Obstruction of Flow 137 137
Output Problem 136 136
Device Operational Issue 124 124
Air Leak 124 124
Failure to Prime 107 107
Inadequate Lighting 101 101
Application Interface Becomes Non-Functional Or Program Exits Abnormally 94 94
Decrease in Pressure 93 93
Unsealed Device Packaging 93 93
Reflux within Device 91 91
Output below Specifications 91 91
Electrical /Electronic Property Problem 89 89
Material Fragmentation 86 86
Computer Operating System Problem 86 86
Loose or Intermittent Connection 83 83
No Device Output 79 79
Application Program Freezes, Becomes Nonfunctional 75 75
Detachment of Device or Device Component 74 74
Device Alarm System 71 71
Optical Problem 70 70
Temperature Problem 68 68
Material Frayed 68 68
Gas/Air Leak 64 64
Contamination 62 62
Partial Blockage 59 59
Gas Output Problem 59 59
Improper Flow or Infusion 57 57
Contamination /Decontamination Problem 57 57
Use of Device Problem 54 54
Insufficient Flow or Under Infusion 52 52
Unstable 50 50
Failure to Fire 47 47
Improper or Incorrect Procedure or Method 46 46
Mechanical Jam 46 46
Display or Visual Feedback Problem 46 46
Computer Software Problem 46 46
Intermittent Energy Output 44 44
Detachment Of Device Component 43 43
Smoking 43 43
Device Emits Odor 43 43
Connection Problem 43 43
Communication or Transmission Problem 42 42
Device Sensing Problem 40 40
Failure to Infuse 39 39
Intermittent Continuity 39 39
Inappropriate or Unexpected Reset 38 38
Component Missing 37 37
Thermal Decomposition of Device 36 36
No Pressure 35 35
Excessive Heating 35 35
Use of Incorrect Control/Treatment Settings 34 34
Sticking 34 34
Difficult to Remove 30 30
Insufficient Heating 30 30
Material Twisted/Bent 30 30
Environmental Compatibility Problem 29 29
Material Separation 29 29
Increase in Pressure 29 29
Component Falling 27 27
Patient-Device Incompatibility 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5861 5862
No Consequences Or Impact To Patient 4856 4856
No Clinical Signs, Symptoms or Conditions 4596 4596
No Patient Involvement 1506 1506
Eye Burn 822 823
Capsular Bag Tear 657 657
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 488 488
No Code Available 439 439
Insufficient Information 331 331
Corneal Edema 329 329
No Information 298 298
Toxic Anterior Segment Syndrome (TASS) 228 228
Inflammation 224 224
Endophthalmitis 221 221
Vitrectomy 197 198
Eye Injury 168 169
Visual Impairment 139 139
Burn, Thermal 121 121
Foreign Body In Patient 109 109
Intraocular Pressure Increased 109 109
Intraocular Pressure Decreased 98 98
Blurred Vision 87 87
Rupture 71 73
Intraocular Pressure, Delayed, Uncontrolled 65 65
Burn(s) 62 62
Hemorrhage/Bleeding 61 61
Fibrosis 58 58
Hypopyon 57 57
Retinal Detachment 57 57
Unspecified Infection 52 52
Device Embedded In Tissue or Plaque 50 50
Eye Pain 49 49
Uveitis 49 49
Loss of Vision 46 46
Toxicity 45 45
Retinal Tear 41 41
Macular Edema 39 39
Vitreous Loss 38 38
Collapse 35 35
Visual Disturbances 33 33
Prolapse 28 28
Conjunctivitis 25 25
Keratitis 24 24
Injury 22 22
Corneal Clouding/Hazing 21 21
Vitreous Floaters 21 21
Edema 20 20
Vitritis 19 19
Swelling 17 17
Fluid Discharge 17 17
Corneal Abrasion 17 17
Complaint, Ill-Defined 16 16
Tissue Damage 15 15
Bacterial Infection 15 15
Corneal Scar 15 15
Retinal Injury 13 13
Pain 13 13
Iritis 12 12
Intraocular Infection 12 12
Foreign Body Reaction 12 12
Discomfort 11 11
Unspecified Eye / Vision Problem 11 11
Clouding, Central Corneal 10 10
Corneal Decompensation 10 10
Hyphema 9 9
Patient Problem/Medical Problem 9 9
Suture Abrasion 8 8
Purulent Discharge 8 8
Swelling/ Edema 8 8
Laceration(s) 7 7
Zonular Dehiscence 7 7
Eye Infections 7 7
Reaction 6 6
Vitreous Detachment 6 6
Phototoxicity 6 6
Red Eye(s) 6 6
Irritation 5 5
Ischemia 5 5
High Blood Pressure/ Hypertension 5 5
Corneal Perforation 5 5
Vitreous Hemorrhage 5 5
Excessive Tear Production 4 4
Discharge 4 4
Corneal Ulcer 4 4
Foreign Body Sensation in Eye 4 4
Drug Resistant Bacterial Infection 4 5
Dry Eye(s) 3 3
Death 3 3
Aspiration/Inhalation 3 3
Capsular Contracture 3 3
Wound Dehiscence 3 3
Hyperemia 3 3
Hematoma 3 3
Failure of Implant 3 3
Nausea 3 3
Occlusion 3 3
Corneal Infiltrates 3 3
Anxiety 3 3
Burning Sensation 3 3
Staphylococcus Aureus 3 3

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 Alcon Research, LTD. II Feb-28-2018
5 Alcon Research, Ltd. II Sep-15-2016
6 Alcon Research, Ltd. II Jun-28-2016
7 Alcon Research, Ltd. II Jun-09-2016
8 Alcon Research, Ltd. II May-03-2016
9 Alcon Research, Ltd. II Jun-29-2015
10 D.O.R.C. Dutch Opthalmic Research Center Intl B.V. II Mar-21-2024
11 Dutch Ophthalmic USA, Inc. II Aug-12-2021
12 Johnson & Johnson Surgical Vision Inc II May-04-2022
13 Johnson & Johnson Surgical Vision, Inc. II Jul-28-2023
14 Johnson & Johnson Surgical Vision, Inc. II Jan-20-2023
15 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
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