PMA P010062S013

Device: Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S013
Product code: NUU
Decision date: 2024-07-18
Classification: Ophthalmic
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: transfer of existing monomer synthesis operations for two monomers from the same supplier to a different manufacturing facility in Riegelwood, NC

Current openFDA PMA Record#

Device: Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S013
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2024-07-18
Decision code: OK30
Date received: 2024-06-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: transfer of existing monomer synthesis operations for two monomers from the same supplier to a different manufacturing facility in Riegelwood, NC