PMA P040029S024

Device
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le
Applicant
Euclid Vision Corporation
Product code
NUU
Decision date
2024-12-23
Generic name
Lens, contact, orthokeratology, overnight
Approval order statement
qualification of an alternate supplier for the tisilfocon A material for overnight wear at the Sterling, Virginia facility

Current openFDA PMA Record#

Device
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le
Applicant
Euclid Vision Corporation
PMA number
P040029
Supplement
S024
Product code
NUU
Generic name
Lens, contact, orthokeratology, overnight
Decision date
2024-12-23
Decision code
OK30
Date received
2024-12-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
qualification of an alternate supplier for the tisilfocon A material for overnight wear at the Sterling, Virginia facility