PMA P910056S038

Device: enVista Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P910056
Supplement: S038
Product code: HQL
Decision date: 2019-08-06
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Elimination of the In-Vitro Pyrogen Testing (IPT) at product release during the Finished Product Inspection of all models of the enVista Hydrophobic Acrylic lntraocular Lens (IOL).

Current openFDA PMA Record#

Device: enVista Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P910056
Supplement: S038
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-08-06
Decision code: OK30
Date received: 2019-07-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Elimination of the In-Vitro Pyrogen Testing (IPT) at product release during the Finished Product Inspection of all models of the enVista Hydrophobic Acrylic lntraocular Lens (IOL).