PMA P850068

Device: SILSOFT (ELASTOFILCON A) CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: P850068
Supplement: S014
Product code: LPM
Decision date: 2022-03-18
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for implementing an alternate packaging configuration and revisions to the cosmetic inspection criteria for the silsoft (elastofilcon A) contact lenses.

Current openFDA PMA Record#

Device: SILSOFT (ELASTOFILCON A) CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: P850068
Supplement: S014
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-03-18
Decision code: APPR
Date received: 2022-02-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for implementing an alternate packaging configuration and revisions to the cosmetic inspection criteria for the silsoft (elastofilcon A) contact lenses.