FDA.reportPublic FDA data

PMA P180035S017

Device
MiSight 1 day (omafilcon A)
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S017
Product code
QIT
Decision date
2023-04-24
Classification
Ophthalmic
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Approval order statement
Manufacture of MiSight 1 Day (omafilcon A) product on Dry Line HF and Wet Line HVF at the Warrior Close manufacturing facility in Chandlers Ford, Eastleigh, UK.

Current openFDA PMA Record#

Device
MiSight 1 day (omafilcon A)
Applicant
CooperVision, Inc.
PMA number
P180035
Supplement
S017
Product code
QIT
Generic name
Daily wear soft contact lens to reduce the progression of myopia
Decision date
2023-04-24
Decision code
OK30
Date received
2023-03-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacture of MiSight 1 Day (omafilcon A) product on Dry Line HF and Wet Line HVF at the Warrior Close manufacturing facility in Chandlers Ford, Eastleigh, UK.