Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 627 627

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 958 958
Failure to Cut 753 753
Appropriate Term/Code Not Available 721 721
Unexpected Shutdown 593 593
Failure to Deliver Energy 531 531
Suction Problem 522 522
Energy Output Problem 493 493
Overheating of Device 465 465
Decrease in Suction 414 414
Suction Failure 333 333
Particulates 327 327
Operating System Becomes Nonfunctional 319 319
Therapeutic or Diagnostic Output Failure 237 237
Inability to Irrigate 235 235
Pressure Problem 194 194
Loss of Power 177 177
Nonstandard Device 164 164
Complete Blockage 155 155
Break 146 146
Defective Device 146 146
Infusion or Flow Problem 120 120
Power Problem 108 108
No Flow 104 104
Defective Component 103 103
Noise, Audible 99 99
Insufficient Information 96 96
Output Problem 95 95
Obstruction of Flow 87 87
Leak/Splash 84 84
Fluid/Blood Leak 75 75
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 52 52
Electrical /Electronic Property Problem 51 51
Computer Operating System Problem 51 51
Failure to Power Up 49 49
Loose or Intermittent Connection 49 49
Gas/Air Leak 48 48
Detachment of Device or Device Component 45 45
Intermittent Energy Output 44 44
Use of Device Problem 42 42
Improper Flow or Infusion 39 39
Contamination /Decontamination Problem 38 38
Reflux within Device 37 37
No Display/Image 37 37
Insufficient Flow or Under Infusion 36 36
No Device Output 35 35
Device Alarm System 35 35
Excessive Heating 34 34
Insufficient Heating 30 30
Failure to Fire 29 29
Display or Visual Feedback Problem 27 27
Computer Software Problem 24 24
Failure to Infuse 24 24
Communication or Transmission Problem 23 23
Material Twisted/Bent 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
Firing Problem 16 16
Environmental Compatibility Problem 16 16
Physical Resistance/Sticking 15 15
Temperature Problem 15 15
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
Increase in Suction 12 12
Component Missing 12 12
Intermittent Continuity 12 12
Crack 11 11
Material Discolored 11 11
Restricted Flow rate 11 11
Excess Flow or Over-Infusion 10 10
Delivered as Unsterile Product 10 10
Use of Incorrect Control/Treatment Settings 10 10
Blocked Connection 10 10
Vibration 10 10
Mechanics Altered 10 10
Failure to Shut Off 10 10
Optical Problem 10 10
Priming 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 4592 4592
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 486 486
Eye Burn 416 417
Capsular Bag Tear 355 355
Insufficient Information 331 331
Toxic Anterior Segment Syndrome (TASS) 228 228
Corneal Edema 198 198
No Patient Involvement 186 186
Endophthalmitis 126 126
No Code Available 110 110
Inflammation 99 99
Intraocular Pressure Decreased 98 98
Blurred Vision 75 75
Eye Injury 74 75
Visual Impairment 65 65
Vitrectomy 60 61
Fibrosis 56 56
Intraocular Pressure Increased 54 54
Hypopyon 49 49
Eye Pain 48 48
Uveitis 44 44
Burn, Thermal 39 39
Foreign Body In Patient 37 37
Hemorrhage/Bleeding 36 36
Retinal Detachment 27 27
Visual Disturbances 26 26
Rupture 26 26
Conjunctivitis 25 25
Vitreous Loss 23 23
Loss of Vision 23 23
Retinal Tear 20 20
Corneal Clouding/Hazing 19 19
No Information 19 19
Burn(s) 18 18
Corneal Abrasion 17 17
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
Iritis 10 10
Corneal Decompensation 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
Pain 6 6
Bacterial Infection 6 6
Suture Abrasion 6 6
Injury 6 6
Patient Problem/Medical Problem 5 5
Corneal Perforation 5 5
Clouding, Central Corneal 5 5
Vitreous Hemorrhage 5 5
Phototoxicity 5 5
Laceration(s) 4 4
Corneal Ulcer 4 4
Edema 4 4
High Blood Pressure/ Hypertension 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
Hyperemia 2 2
Failure of Implant 2 2
Glaucoma 2 2
Hematoma 2 2
Dry Eye(s) 2 2
Wound Dehiscence 2 2
Capsular Contracture 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
Cataract 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 Jul-28-2023
8 Johnson & Johnson Surgical Vision, Inc. II Jan-20-2023
9 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
-
-