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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 7
ABBOTT MEDICAL OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALCON LENSX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON MANUFACTURING, LTD.
  SUBSTANTIALLY EQUIVALENT 4
ALCON RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 3
BAUSCH & LOMB
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
LENSAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
LENSTEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OERTLI INSTRUMENTE AG
  SUBSTANTIALLY EQUIVALENT 1
RAICO LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2739 2739
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 2348 2348
Failure to Cut 2163 2163
Adverse Event Without Identified Device or Use Problem 1818 1818
Device Displays Incorrect Message 1338 1338
Suction Problem 1166 1166
Aspiration Issue 1116 1116
Loss of Power 1070 1070
Device Inoperable 1041 1041
Appropriate Term/Code Not Available 940 940
Overheating of Device 626 626
Decrease in Suction 605 605
Unexpected Shutdown 605 605
Device Operational Issue 563 563
Failure to Deliver Energy 547 547
Energy Output Problem 506 506
Particulates 503 503
Operating System Becomes Nonfunctional 470 470
Insufficient Information 463 463
Inability to Irrigate 442 442
Occlusion Within Device 372 372
Suction Failure 339 339
Break 338 338
Complete Blockage 332 332
Pressure Problem 321 321
Difficult to Insert 320 320
Leak/Splash 286 286
Failure to Power Up 278 278
Defective Device 274 274
Fluid/Blood Leak 255 255
Infusion or Flow Problem 251 251
Power Problem 250 250
Therapeutic or Diagnostic Output Failure 239 239
Noise, Audible 200 200
Device Stops Intermittently 186 186
No Flow 177 177
No Display/Image 170 170
Nonstandard Device 166 166
Mechanical Problem 163 163
Air Leak 158 158
Defective Component 158 158
Self-Activation or Keying 149 149
Device Contamination with Chemical or Other Material 149 149
Obstruction of Flow 146 146
Output Problem 137 137
Inadequate Lighting 127 127
Failure to Prime 123 123
Decrease in Pressure 104 104
Reflux within Device 97 97
Application Interface Becomes Non-Functional Or Program Exits Abnormally 97 97
Loose or Intermittent Connection 95 95
Unsealed Device Packaging 93 93
Electrical /Electronic Property Problem 93 93
Output below Specifications 92 92
Computer Operating System Problem 90 90
Material Fragmentation 90 90
No Device Output 82 82
Detachment of Device or Device Component 79 79
Application Program Freezes, Becomes Nonfunctional 75 75
Device Alarm System 72 72
Optical Problem 70 70
Use of Device Problem 70 70
Insufficient Flow or Under Infusion 69 69
Temperature Problem 69 69
Material Frayed 68 68
Gas/Air Leak 67 67
Partial Blockage 65 65
Improper Flow or Infusion 64 64
Gas Output Problem 63 63
Contamination 62 62
Failure to Infuse 59 59
Connection Problem 58 58
Contamination /Decontamination Problem 57 57
Unstable 51 51
Device Emits Odor 51 51
Device Issue 50 50
Improper or Incorrect Procedure or Method 50 50
Smoking 50 50
Failure to Fire 49 49
Communication or Transmission Problem 48 48
Mechanical Jam 48 48
Display or Visual Feedback Problem 48 48
Computer Software Problem 48 48
Detachment Of Device Component 45 45
Device Sensing Problem 44 44
Intermittent Energy Output 44 44
Intermittent Continuity 42 42
No Pressure 41 41
Thermal Decomposition of Device 41 41
Excess Flow or Over-Infusion 40 40
Sticking 39 39
Component Missing 39 39
Inappropriate or Unexpected Reset 38 38
Excessive Heating 35 35
Use of Incorrect Control/Treatment Settings 35 35
Material Twisted/Bent 32 32
Difficult to Remove 31 31
Insufficient Heating 30 30
Increase in Pressure 30 30
Disconnection 30 30
Environmental Compatibility Problem 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6434 6434
No Known Impact Or Consequence To Patient 6182 6183
No Clinical Signs, Symptoms or Conditions 4596 4596
No Patient Involvement 1755 1755
Eye Burn 901 902
Capsular Bag Tear 789 789
No Code Available 563 563
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 488 488
No Information 394 394
Corneal Edema 359 359
Insufficient Information 331 331
Inflammation 274 274
Vitrectomy 266 267
Endophthalmitis 254 254
Toxic Anterior Segment Syndrome (TASS) 228 228
Eye Injury 185 186
Visual Impairment 154 154
Burn, Thermal 147 147
Foreign Body In Patient 129 129
Intraocular Pressure Increased 121 121
Intraocular Pressure, Delayed, Uncontrolled 109 109
Intraocular Pressure Decreased 98 98
Blurred Vision 90 90
Rupture 75 77
Retinal Detachment 71 71
Hemorrhage/Bleeding 71 71
Hypopyon 69 69
Burn(s) 63 63
Fibrosis 58 58
Device Embedded In Tissue or Plaque 56 56
Unspecified Infection 54 54
Loss of Vision 53 53
Uveitis 49 49
Eye Pain 49 49
Retinal Tear 47 47
Toxicity 45 45
Vitreous Loss 43 43
Macular Edema 42 42
Collapse 39 39
Visual Disturbances 33 33
Prolapse 32 32
Conjunctivitis 25 25
Keratitis 25 25
Vitritis 25 25
Corneal Clouding/Hazing 25 25
Vitreous Floaters 24 24
Injury 23 23
Edema 22 22
Pain 20 20
Retinal Injury 18 18
Corneal Abrasion 18 18
Swelling 17 17
Complaint, Ill-Defined 17 17
Fluid Discharge 17 17
Tissue Damage 16 16
Bacterial Infection 15 15
Corneal Scar 15 15
Discomfort 13 13
Intraocular Infection 13 13
Iritis 12 12
Foreign Body Reaction 12 12
Unspecified Eye / Vision Problem 11 11
Corneal Decompensation 11 11
Hyphema 11 11
Clouding, Central Corneal 10 10
Corneal Ulcer 10 10
Corneal Perforation 9 9
Patient Problem/Medical Problem 9 9
Swelling/ Edema 8 8
Zonular Dehiscence 8 8
Suture Abrasion 8 8
Purulent Discharge 8 8
Eye Infections 7 7
Phototoxicity 7 7
Vitreous Detachment 7 7
Laceration(s) 7 7
Reaction 6 6
Ischemia 6 6
Red Eye(s) 6 6
Foreign Body Sensation in Eye 6 6
Vitreous Hemorrhage 6 6
Irritation 5 5
High Blood Pressure/ Hypertension 5 5
Staphylococcus Aureus 5 5
Wrinkling 5 5
Burning Sensation 4 4
Corneal Infiltrates 4 4
Drug Resistant Bacterial Infection 4 5
Excessive Tear Production 4 4
Death 4 4
Discharge 4 4
Deposits 4 4
Dry Eye(s) 4 4
Chemosis 3 3
Occlusion 3 3
Hematoma 3 3
Wound Dehiscence 3 3
Capsular Contracture 3 3
Cataract 3 3
Aspiration/Inhalation 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics, Inc. II Jul-09-2013
2 Alcon Research LLC II Apr-23-2020
3 Alcon Research LTD dba Alcon Laboratories, Inc. I Jul-13-2010
4 Alcon Research, LLC II Oct-11-2023
5 Alcon Research, LTD. II Aug-16-2023
6 Alcon Research, LTD. II Feb-28-2018
7 Alcon Research, Ltd. II Sep-15-2016
8 Alcon Research, Ltd. II Jun-28-2016
9 Alcon Research, Ltd. II Jun-09-2016
10 Alcon Research, Ltd. II May-03-2016
11 Alcon Research, Ltd. II Jun-29-2015
12 Alcon Research, Ltd. II Dec-04-2014
13 American Optisurgical Inc II Sep-04-2009
14 Bausch & Lomb Inc II Dec-20-2012
15 Bausch & Lomb Inc II Aug-30-2011
16 Bausch & Lomb Inc II May-28-2010
17 D.O.R.C. Dutch Opthalmic Research Center Intl B.V. II Mar-21-2024
18 Dutch Ophthalmic USA, Inc. II Aug-12-2021
19 Johnson & Johnson Surgical Vision Inc II May-04-2022
20 Johnson & Johnson Surgical Vision, Inc. II Jul-28-2023
21 Johnson & Johnson Surgical Vision, Inc. II Jan-20-2023
22 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
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