• 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
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 152 152

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 913 913
Failure to Cut 715 715
Appropriate Term/Code Not Available 687 687
Unexpected Shutdown 571 571
Failure to Deliver Energy 506 506
Suction Problem 495 495
Energy Output Problem 481 481
Overheating of Device 462 462
Decrease in Suction 405 405
Operating System Becomes Nonfunctional 316 316
Suction Failure 313 313
Particulates 309 309
Therapeutic or Diagnostic Output Failure 237 237
Inability to Irrigate 222 222
Pressure Problem 192 192
Loss of Power 176 176
Complete Blockage 151 151
Defective Device 146 146
Break 142 142
Infusion or Flow Problem 113 113
Power Problem 107 107
Defective Component 102 102
No Flow 100 100
Noise, Audible 97 97
Insufficient Information 96 96
Output Problem 94 94
Obstruction of Flow 85 85
Leak/Splash 84 84
Fluid/Blood Leak 75 75
Unsealed Device Packaging 73 73
Device Displays Incorrect Message 72 72
Decrease in Pressure 70 70
Application Program Freezes, Becomes Nonfunctional 70 70
Failure to Prime 69 69
Mechanical Problem 63 63
Self-Activation or Keying 58 58
Material Fragmentation 54 54
Gas Output Problem 53 53
Electrical /Electronic Property Problem 51 51
Contamination 50 50
Computer Operating System Problem 50 50
Failure to Power Up 48 48
Gas/Air Leak 47 47
Detachment of Device or Device Component 45 45
Loose or Intermittent Connection 44 44
Intermittent Energy Output 43 43
Use of Device Problem 42 42
Contamination /Decontamination Problem 38 38
No Display/Image 37 37
Insufficient Flow or Under Infusion 36 36
Reflux within Device 35 35
Device Alarm System 35 35
Improper Flow or Infusion 31 31
Insufficient Heating 30 30
No Device Output 29 29
Failure to Fire 28 28
Display or Visual Feedback Problem 27 27
Excessive Heating 27 27
Computer Software Problem 24 24
Communication or Transmission Problem 23 23
Material Twisted/Bent 22 22
Failure to Infuse 21 21
Increase in Pressure 19 19
Backflow 19 19
Connection Problem 19 19
Activation Problem 19 19
Device Emits Odor 17 17
Environmental Compatibility Problem 16 16
Output below Specifications 16 16
No Pressure 16 16
Firing 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
Material Discolored 11 11
Use of Incorrect Control/Treatment Settings 10 10
Crack 10 10
Excess Flow or Over-Infusion 10 10
Restricted Flow rate 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
Delivered as Unsterile Product 9 9
Partial Blockage 9 9
Accessory Incompatible 8 8
Flushing Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4279 4279
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 478 478
Eye Burn 397 398
Capsular Bag Tear 342 342
Insufficient Information 259 259
Toxic Anterior Segment Syndrome (TASS) 226 226
No Patient Involvement 186 186
Corneal Edema 166 166
Endophthalmitis 126 126
No Code Available 110 110
Inflammation 97 97
Intraocular Pressure Decreased 94 94
Eye Injury 73 74
Vitrectomy 60 61
Fibrosis 56 56
Intraocular Pressure Increased 54 54
Visual Impairment 50 50
Hypopyon 49 49
Eye Pain 48 48
Uveitis 44 44
Blurred Vision 41 41
Burn, Thermal 39 39
Foreign Body In Patient 37 37
Hemorrhage/Bleeding 36 36
Retinal Detachment 27 27
Rupture 26 26
Conjunctivitis 25 25
Visual Disturbances 24 24
Vitreous Loss 23 23
Loss of Vision 23 23
Retinal Tear 20 20
No Information 19 19
Corneal Abrasion 17 17
Corneal Clouding/Hazing 17 17
Vitreous Floaters 16 16
Macular Edema 16 16
Burn(s) 15 15
Prolapse 15 15
Intraocular Pressure, Delayed, Uncontrolled 14 14
Corneal Scar 13 13
Collapse 13 13
Vitritis 12 12
Swelling 11 11
Iritis 10 10
Unspecified Eye / Vision Problem 10 10
Corneal Decompensation 9 9
Purulent Discharge 8 8
Device Embedded In Tissue or Plaque 8 8
Swelling/ Edema 8 8
Fluid Discharge 7 7
Intraocular Infection 7 7
Hyphema 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
Eye Infections 3 3
Red Eye(s) 3 3
Nausea 2 2
Irritation 2 2
Halo 2 2
Hematoma 2 2
Failure of Implant 2 2
Glaucoma 2 2
Hyperemia 2 2
Dry Eye(s) 2 2
Capsular Contracture 2 2
Cerebral Edema 2 2
Superficial (First Degree) Burn 2 2
Cusp Tear 2 2
Tissue Breakdown 1 1
Chemical Exposure 1 1
Post Operative Wound Infection 1 1
Skin Tears 1 1
Deformity/ Disfigurement 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Cataract 1 1
Chemosis 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 Dutch Ophthalmic USA, Inc. II Aug-12-2021
5 Johnson & Johnson Surgical Vision Inc II May-04-2022
6 Johnson & Johnson Surgical Vision, Inc. II Jul-28-2023
7 Johnson & Johnson Surgical Vision, Inc. II Jan-20-2023
8 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
-
-