PMA P930014S112

Device: AcrySof Posteriior Chamber Single Piece Intraocular Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S112
Product code: HQL
Decision date: 2018-07-31
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval for a second alternate sterilization chamber at the contract sterilization site for the AcrySof® and AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses.

Current openFDA PMA Record#

Device: AcrySof Posteriior Chamber Single Piece Intraocular Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P930014
Supplement: S112
Product code: HQL
Generic name: intraocular lens
Decision date: 2018-07-31
Decision code: APPR
Date received: 2018-05-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a second alternate sterilization chamber at the contract sterilization site for the AcrySof® and AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses.