PMA N16895S107

Device: Bausch & Lomb SofLens® (polymacon) Contact Lenses
Applicant: Bausch & Lomb, Inc.
PMA number: N16895
Supplement: S107
Product code: LPM
Decision date: 2025-10-24
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: use of a New Technology Moulding Machine in the Reverse Process III (RPIII) manufacturing process utilized in the Bausch + Lomb Waterford, Ireland manufacturing facility

Current openFDA PMA Record#

Device: Bausch & Lomb SofLens® (polymacon) Contact Lenses
Applicant: Bausch & Lomb, Inc.
PMA number: N16895
Supplement: S107
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-10-24
Decision code: OK30
Date received: 2025-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: use of a New Technology Moulding Machine in the Reverse Process III (RPIII) manufacturing process utilized in the Bausch + Lomb Waterford, Ireland manufacturing facility