PMA P910056S065

Device: enVista Aspire™ Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P910056
Supplement: S065
Product code: HQL
Decision date: 2026-09-29
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: change from a manual to an automatic process in the secondary packaging system of the enVista Aspire Intraocular lenses (IOLs), Models EA and ETA

Current openFDA PMA Record#

Device: enVista Aspire™ Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P910056
Supplement: S065
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-09-29
Decision code: OK30
Date received: 2026-09-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change from a manual to an automatic process in the secondary packaging system of the enVista Aspire Intraocular lenses (IOLs), Models EA and ETA