• 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 accessories, soft lens products
Product CodeLPN
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
CHEMTEX USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OTE NORTH AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
THE LIFESTYLE COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2665 2665
2018 95 95
2019 60 60
2020 82 82
2021 50 50
2022 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2562 2562
Adverse Event Without Identified Device or Use Problem 191 191
Device Markings/Labelling Problem 36 36
Patient-Device Incompatibility 34 34
Contamination 29 29
Improper or Incorrect Procedure or Method 28 28
Insufficient Information 25 25
Device Operates Differently Than Expected 15 15
Material Integrity Problem 8 8
Contamination /Decontamination Problem 8 8
Labelling, Instructions for Use or Training Problem 7 7
Use of Device Problem 5 5
Appropriate Term/Code Not Available 5 5
Packaging Problem 5 5
No Apparent Adverse Event 4 4
Nonstandard Device 4 4
Device Handling Problem 4 4
Off-Label Use 3 3
Break 3 3
Microbial Contamination of Device 3 3
Defective Device 3 3
Output Problem 3 3
Inadequate Instructions for Non-Healthcare Professional 3 3
Improper Chemical Reaction 3 3
Chemical Problem 2 2
Component Missing 2 2
Patient Device Interaction Problem 2 2
Protective Measures Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Defective Component 1 1
Device Ingredient or Reagent Problem 1 1
Accessory Incompatible 1 1
Device Inoperable 1 1
Human Factors Issue 1 1
Difficult to Remove 1 1
Expiration Date Error 1 1
Device Reprocessing Problem 1 1
Failure to Disinfect 1 1
Device Emits Odor 1 1
Difficult to Open or Close 1 1
Fluid Leak 1 1
Pumping Stopped 1 1
Inadequate User Interface 1 1
Physical Property Issue 1 1
Device Rinsing Issue 1 1
Fungus in Device Environment 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 2434 2434
Red Eye(s) 313 313
Irritation 230 230
Pain 210 210
Discomfort 129 129
Excessive Tear Production 87 87
Blurred Vision 74 74
No Consequences Or Impact To Patient 64 64
Corneal Ulcer 48 48
Swelling 43 43
Itching Sensation 42 42
Keratitis 42 42
Dry Eye(s) 38 38
Conjunctivitis 35 35
Eye Burn 31 31
No Known Impact Or Consequence To Patient 30 30
Unspecified Infection 26 26
Erythema 25 25
Corneal Abrasion 25 25
Inflammation 24 24
Caustic/Chemical Burns 22 22
Reaction 22 22
Eye Injury 20 20
Corneal Edema 17 17
Corneal Scar 17 17
Loss of Vision 17 17
No Code Available 17 17
Eye Pain 15 15
Visual Disturbances 15 15
Hyperemia 14 14
Headache 13 13
Visual Impairment 13 13
Discharge 13 13
Foreign Body Sensation in Eye 10 10
Bacterial Infection 9 9
Corneal Infiltrates 9 9
Halo 8 8
Increased Sensitivity 7 7
Erosion 7 7
Corneal Clouding/Hazing 7 7
Intraocular Infection 6 6
Acanthameba Keratitis 6 6
Fungal Infection 6 6
No Patient Involvement 6 6
Patient Problem/Medical Problem 5 5
Eye Infections 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Information 4 4
Nausea 4 4
Neovascularization 3 3
Skin Irritation 3 3
Ulcer 3 3
Iritis 3 3
Hypersensitivity/Allergic reaction 3 3
Edema 3 3
Purulent Discharge 3 3
Swelling/ Edema 3 3
Foreign Body In Patient 3 3
Dizziness 3 3
Ptosis 2 2
Fluid Discharge 2 2
Chemical Exposure 2 2
Complaint, Ill-Defined 2 2
Injury 2 2
Insufficient Information 2 2
Skin Inflammation/ Irritation 2 2
Burn(s) 2 2
Chemosis 2 2
Wound Dehiscence 2 2
Abscess 2 2
Hypopyon 2 2
Overwear Syndrome 2 2
Uveitis 2 2
Scarring 2 2
Scar Tissue 1 1
Therapeutic Effects, Unexpected 1 1
Optical Tissue, Breakdown Of 1 1
Ulceration 1 1
Ischemia 1 1
Peeling 1 1
Rash 1 1
Local Reaction 1 1
Skin Discoloration 1 1
Vitreous Hemorrhage 1 1
Chills 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Miscarriage 1 1
Autoimmune Disorder 1 1
Abdominal Pain 1 1
Abrasion 1 1
Exposure to Body Fluids 1 1
Endophthalmitis 1 1
Corneal Perforation 1 1
Contact Dermatitis 1 1
Reaction to Medicinal Component of Device 1 1
Unspecified Eye / Vision Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC II Feb-03-2021
2 Family Dollar Stores, Llc. II Aug-17-2022
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
-
-