PMA P910056S036

Device: enVista One Piece Hydrophobic Acrylic Intraocular Lens
Applicant: Bausch & Lomb, Inc.
PMA number: P910056
Supplement: S036
Product code: HQL
Decision date: 2019-07-02
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval of the enVista® One Piece Hydrophobic Acrylic IOL, Model MX60ET, which includes a modification to the intraocular lens (IOL) material formulation of the approved parent lens, enVista® Model MX60T.

Current openFDA PMA Record#

Device: enVista One Piece Hydrophobic Acrylic Intraocular Lens
Applicant: Bausch & Lomb, Inc.
PMA number: P910056
Supplement: S036
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-07-02
Decision code: APPR
Date received: 2019-04-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval of the enVista® One Piece Hydrophobic Acrylic IOL, Model MX60ET, which includes a modification to the intraocular lens (IOL) material formulation of the approved parent lens, enVista® Model MX60T.