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 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
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
2018 95 95
2019 60 60
2020 82 82
2021 50 50
2022 62 62
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 154 154
Device Markings/Labelling Problem 35 35
Product Quality Problem 31 31
Contamination 30 30
Improper or Incorrect Procedure or Method 21 21
Patient-Device Incompatibility 21 21
Labelling, Instructions for Use or Training Problem 13 13
Insufficient Information 12 12
Contamination /Decontamination Problem 8 8
Device Emits Odor 7 7
No Apparent Adverse Event 4 4
Patient Device Interaction Problem 4 4
Device Handling Problem 3 3
Material Integrity Problem 3 3
Improper Chemical Reaction 3 3
Output Problem 3 3
Use of Device Problem 3 3
Defective Device 3 3
Nonstandard Device 3 3
Break 2 2
Microbial Contamination of Device 2 2
Component Missing 2 2
Fungus in Device Environment 2 2
Off-Label Use 2 2
Chemical Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Appropriate Term/Code Not Available 2 2
Inadequate User Interface 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Accessory Incompatible 1 1
Difficult to Remove 1 1
Defective Component 1 1
Device Reprocessing Problem 1 1
Failure to Disinfect 1 1
Fluid/Blood Leak 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 110 110
Pain 65 65
Red Eye(s) 60 60
Discomfort 38 38
Corneal Ulcer 38 38
Irritation 34 34
Keratitis 28 28
Blurred Vision 27 27
Eye Burn 26 26
No Known Impact Or Consequence To Patient 26 26
Excessive Tear Production 22 22
Eye Pain 20 20
Corneal Abrasion 18 18
Corneal Scar 17 17
No Clinical Signs, Symptoms or Conditions 17 17
Swelling 16 16
Erythema 15 15
Dry Eye(s) 14 14
Hyperemia 14 14
Inflammation 13 13
Eye Injury 13 13
Conjunctivitis 13 13
Corneal Edema 13 13
Unspecified Infection 12 12
No Code Available 12 12
Loss of Vision 11 11
Visual Impairment 10 10
Itching Sensation 10 10
Headache 9 9
Caustic/Chemical Burns 9 9
Eye Infections 9 9
Corneal Infiltrates 8 8
Discharge 6 6
Reaction 6 6
Foreign Body Sensation in Eye 6 6
Corneal Clouding/Hazing 6 6
Swelling/ Edema 6 6
Insufficient Information 5 5
Patient Problem/Medical Problem 5 5
Acanthameba Keratitis 5 5
Erosion 5 5
Fungal Infection 5 5
Increased Sensitivity 5 5
Visual Disturbances 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body In Patient 3 3
Skin Irritation 3 3
Skin Inflammation/ Irritation 3 3
Nausea 3 3
Dizziness 3 3
Overwear Syndrome 3 3
Purulent Discharge 3 3
Intraocular Infection 3 3
Bacterial Infection 2 2
Ulcer 2 2
Injury 2 2
Unspecified Eye / Vision Problem 2 2
Fluid Discharge 2 2
Ptosis 2 2
No Patient Involvement 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1
Contact Dermatitis 1 1
Nodule 1 1
Reaction to Medicinal Component of Device 1 1
Hallucination 1 1
Corneal Epithelial Microcysts 1 1
Chemical Exposure 1 1
Weight Changes 1 1
No Consequences Or Impact To Patient 1 1
Halo 1 1
Neovascularization 1 1
Local Reaction 1 1
Skin Discoloration 1 1
Scarring 1 1
Vitreous Hemorrhage 1 1
Chills 1 1
Uveitis 1 1
Exposure to Body Fluids 1 1
Abdominal Pain 1 1
Abscess 1 1
Burn(s) 1 1
Chemosis 1 1
Vitreous Floaters 1 1
Edema 1 1
Endophthalmitis 1 1
Iritis 1 1
Hypopyon 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Miscarriage 1 1
Ischemia 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
-
-