PMA P880087S031

Device: Single-Piece PMMA Anterior Chamber IOLs
Applicant: Alcon Laboratories
PMA number: P880087
Supplement: S031
Product code: HQL
Decision date: 2021-12-02
Generic name: intraocular lens
Approval order statement: Approval for a manufacturing site located at PT. CIBA VISION Batam located at Jalan Beringin Kav. #204, Batamindo Industrial Park, Muka Kuning Batam Island, 29433 Indonesia for manufacturing, packaging, and sterilization.

Current openFDA PMA Record#

Device: Single-Piece PMMA Anterior Chamber IOLs
Applicant: Alcon Laboratories
PMA number: P880087
Supplement: S031
Product code: HQL
Generic name: intraocular lens
Decision date: 2021-12-02
Decision code: APPR
Date received: 2021-06-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at PT. CIBA VISION Batam located at Jalan Beringin Kav. #204, Batamindo Industrial Park, Muka Kuning Batam Island, 29433 Indonesia for manufacturing, packaging, and sterilization.