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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 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
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 791 791

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 984 984
Failure to Cut 775 775
Appropriate Term/Code Not Available 724 724
Unexpected Shutdown 602 602
Failure to Deliver Energy 544 544
Suction Problem 530 530
Energy Output Problem 497 497
Overheating of Device 470 470
Decrease in Suction 415 415
Suction Failure 344 344
Particulates 336 336
Operating System Becomes Nonfunctional 323 323
Inability to Irrigate 245 245
Therapeutic or Diagnostic Output Failure 237 237
Pressure Problem 201 201
Loss of Power 178 178
Nonstandard Device 173 173
Complete Blockage 158 158
Break 149 149
Defective Device 146 146
Infusion or Flow Problem 120 120
Power Problem 108 108
No Flow 107 107
Defective Component 104 104
Noise, Audible 103 103
Output Problem 97 97
Insufficient Information 96 96
Obstruction of Flow 88 88
Leak/Splash 85 85
Fluid/Blood Leak 76 76
Unsealed Device Packaging 74 74
Application Program Freezes, Becomes Nonfunctional 73 73
Device Displays Incorrect Message 72 72
Decrease in Pressure 71 71
Failure to Prime 69 69
Mechanical Problem 64 64
Self-Activation or Keying 58 58
Gas Output Problem 56 56
Material Fragmentation 55 55
Contamination 53 53
Electrical /Electronic Property Problem 51 51
Loose or Intermittent Connection 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
Intermittent Energy Output 44 44
Improper Flow or Infusion 43 43
Use of Device Problem 43 43
Contamination /Decontamination Problem 38 38
Reflux within Device 37 37
No Display/Image 37 37
No Device Output 36 36
Insufficient Flow or Under Infusion 36 36
Excessive Heating 36 36
Device Alarm System 35 35
Insufficient Heating 31 31
Failure to Fire 29 29
Display or Visual Feedback Problem 27 27
Material Twisted/Bent 25 25
Computer Software Problem 24 24
Failure to Infuse 24 24
Communication or Transmission Problem 23 23
Connection Problem 20 20
Activation Problem 19 19
Increase in Pressure 19 19
Backflow 19 19
Device Emits Odor 17 17
No Pressure 17 17
Output below Specifications 16 16
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
Mechanical Jam 12 12
Inappropriate or Unexpected Reset 12 12
Priming Problem 12 12
Increase in Suction 12 12
Component Missing 12 12
Intermittent Continuity 12 12
Restricted Flow rate 12 12
Crack 11 11
Material Discolored 11 11
Use of Incorrect Control/Treatment Settings 10 10
Excess Flow or Over-Infusion 10 10
Delivered as Unsterile Product 10 10
Blocked Connection 10 10
Vibration 10 10
Mechanics Altered 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 4664 4664
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 499 499
Eye Burn 437 438
Insufficient Information 380 380
Capsular Bag Tear 358 358
Toxic Anterior Segment Syndrome (TASS) 228 228
Corneal Edema 208 208
No Patient Involvement 186 186
Endophthalmitis 126 126
No Code Available 110 110
Intraocular Pressure Decreased 103 103
Inflammation 99 99
Blurred Vision 84 84
Eye Injury 77 78
Visual Impairment 65 65
Vitrectomy 60 61
Fibrosis 56 56
Intraocular Pressure Increased 55 55
Hypopyon 49 49
Eye Pain 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 27 27
Conjunctivitis 25 25
Corneal Clouding/Hazing 23 23
Vitreous Loss 23 23
Loss of Vision 23 23
Retinal Tear 22 22
Burn(s) 22 22
No Information 19 19
Corneal Abrasion 18 18
Macular Edema 16 16
Vitreous Floaters 16 16
Prolapse 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
Fluid Discharge 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
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
Zonular Dehiscence 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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