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 daily wear soft contact lens to reduce the progression of myopia
Definition Intended to be worn on the surface of the eye in children who have myopia to: • Reduce the rate of progression of myopia, and • Optically correct myopic refractive error.
Product CodeQIT
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
0 1 4 4 4 5

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anaphylactic Shock 2 2
Hypersensitivity/Allergic reaction 2 2
Eye Infections 2 2
Eye Pain 1 1
Insufficient Information 1 1
Keratitis 1 1
Acanthameba Keratitis 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Halo 1 1
Bacterial Infection 1 1
Corneal Ulcer 1 1
Corneal Clouding/Hazing 1 1

-
-