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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH + LOMB
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 2
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
2017 2781 2781
2018 2413 2413
2019 2287 2287
2020 1217 1217
2021 1673 1673
2022 1628 1628

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1054 1054
Adverse Event Without Identified Device or Use Problem 1034 1034
Device Operates Differently Than Expected 667 667
Suction Problem 622 622
Appropriate Term/Code Not Available 568 568
Loss of Power 483 483
Overheating of Device 467 467
Unexpected Shutdown 407 407
Device Inoperable 364 364
Decrease in Suction 336 336
Particulates 335 335
Device Displays Incorrect Message 327 327
Aspiration Issue 322 322
Failure to Deliver Energy 298 298
Energy Output Problem 294 294
Defective Device 249 249
Inability to Irrigate 247 247
Insufficient Information 246 246
Therapeutic or Diagnostic Output Failure 237 237
Suction Failure 236 236
Operating System Becomes Nonfunctional 207 207
Break 183 183
Leak/Splash 176 176
Power Problem 176 176
Complete Blockage 169 169
Pressure Problem 167 167
Fluid/Blood Leak 162 162
Failure to Power Up 128 128
Defective Component 125 125
Output Problem 117 117
Noise, Audible 112 112
Mechanical Problem 111 111
Occlusion Within Device 103 103
Obstruction of Flow 101 101
Self-Activation or Keying 95 95
Unsealed Device Packaging 91 91
Infusion or Flow Problem 90 90
Device Contamination with Chemical or Other Material 88 88
Device Stops Intermittently 79 79
No Flow 77 77
Material Fragmentation 68 68
Application Program Freezes, Becomes Nonfunctional 67 67
No Display/Image 65 65
Decrease in Pressure 64 64
Device Operational Issue 62 62
No Device Output 60 60
Detachment of Device or Device Component 57 57
Device Alarm System 56 56
Computer Operating System Problem 55 55
Gas/Air Leak 53 53
Air Leak 53 53
Contamination /Decontamination Problem 51 51
Output below Specifications 50 50
Electrical /Electronic Property Problem 50 50
Difficult to Insert 49 49
Loose or Intermittent Connection 43 43
Failure to Prime 42 42
Temperature Problem 42 42
Computer Software Problem 41 41
Partial Blockage 40 40
Application Interface Becomes Non-Functional Or Program Exits Abnormally 37 37
Use of Device Problem 36 36
Contamination 34 34
Intermittent Continuity 33 33
Failure to Fire 33 33
Inappropriate or Unexpected Reset 31 31
Inadequate Lighting 31 31
Improper Flow or Infusion 30 30
Smoking 30 30
Reflux within Device 28 28
Display or Visual Feedback Problem 28 28
Gas Output Problem 28 28
Intermittent Energy Output 28 28
Mechanical Jam 27 27
Detachment Of Device Component 25 25
Material Separation 25 25
Increase in Pressure 24 24
Component Missing 24 24
Patient-Device Incompatibility 23 23
Insufficient Flow or Under Infusion 23 23
Use of Incorrect Control/Treatment Settings 22 22
Optical Problem 22 22
Communication or Transmission Problem 21 21
Connection Problem 21 21
Unstable 21 21
Device Emits Odor 21 21
Improper or Incorrect Procedure or Method 20 20
Failure to Infuse 20 20
Activation Problem 20 20
Intermittent Loss of Power 20 20
Environmental Compatibility Problem 18 18
No Pressure 18 18
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Insufficient Heating 17 17
Restricted Flow rate 16 16
Failure to Read Input Signal 16 16
Material Twisted/Bent 16 16
Protective Measures Problem 16 16
Mechanics Altered 15 15
Physical Resistance/Sticking 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3757 3757
No Clinical Signs, Symptoms or Conditions 2622 2622
No Consequences Or Impact To Patient 2413 2413
No Patient Involvement 471 471
Eye Burn 464 465
Capsular Bag Tear 444 444
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
No Code Available 259 259
Corneal Edema 198 198
Insufficient Information 188 188
Toxic Anterior Segment Syndrome (TASS) 167 167
Endophthalmitis 157 157
No Information 150 150
Vitrectomy 143 144
Inflammation 124 124
Eye Injury 107 108
Burn, Thermal 91 91
Foreign Body In Patient 71 71
Intraocular Pressure Increased 57 57
Visual Impairment 57 57
Intraocular Pressure Decreased 52 52
Uveitis 47 47
Intraocular Pressure, Delayed, Uncontrolled 43 43
Unspecified Infection 41 41
Hemorrhage/Bleeding 41 41
Device Embedded In Tissue or Plaque 37 37
Hypopyon 36 36
Macular Edema 34 34
Retinal Detachment 34 34
Blurred Vision 34 34
Rupture 34 36
Loss of Vision 27 27
Retinal Tear 25 25
Collapse 23 23
Toxicity 22 22
Vitreous Loss 19 19
Burn(s) 19 19
Prolapse 18 18
Eye Pain 18 18
Vitritis 16 16
Conjunctivitis 15 15
Edema 15 15
Vitreous Floaters 14 14
Swelling 14 14
Visual Disturbances 11 11
Injury 11 11
Keratitis 9 9
Bacterial Infection 9 9
Retinal Injury 8 8
Pain 8 8
Suture Abrasion 8 8
Unspecified Eye / Vision Problem 7 7
Patient Problem/Medical Problem 7 7
Swelling/ Edema 7 7
Corneal Decompensation 7 7
Corneal Scar 7 7
Corneal Clouding/Hazing 7 7
Zonular Dehiscence 6 6
Clouding, Central Corneal 6 6
Discomfort 5 5
Complaint, Ill-Defined 5 5
Fluid Discharge 5 5
Corneal Perforation 5 5
Corneal Abrasion 5 5
Intraocular Infection 5 5
Iritis 4 4
Vitreous Hemorrhage 4 4
Phototoxicity 4 4
Corneal Ulcer 4 4
High Blood Pressure/ Hypertension 4 4
Fibrosis 4 4
Drug Resistant Bacterial Infection 4 5
Reaction 3 3
Wrinkling 3 3
Vitreous Detachment 3 3
Excessive Tear Production 3 3
Hyphema 3 3
Failure of Implant 3 3
Hematoma 3 3
Purulent Discharge 3 3
Red Eye(s) 3 3
Tissue Damage 3 3
Staphylococcus Aureus 3 3
Laceration(s) 3 3
Occlusion 3 3
Nausea 2 2
Perforation 2 2
Irritation 2 2
Toxic Shock Syndrome 2 2
Fall 2 2
Hyperemia 2 2
Aspiration/Inhalation 2 2
Bruise/Contusion 2 2
Capsular Contracture 2 2
Cataract 2 2
Chemosis 2 2
Corneal Infiltrates 2 2
Halo 2 2
Anxiety 2 2
Skin Tears 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Apr-23-2020
2 Alcon Research, LTD. II Feb-28-2018
3 Dutch Ophthalmic USA, Inc. II Aug-12-2021
4 Johnson & Johnson Surgical Vision Inc II May-04-2022
5 Johnson & Johnson Surgical Vision, Inc. II Oct-12-2022
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