PMA P080004S031

Device: iSert Preloaded System
Applicant: Hoya Surgical Optics, Inc.
Product code: HQL
Decision date: 2021-05-21
Generic name: intraocular lens
Approval order statement: Approval for a manufacturing site located at HOYA Lamphun Ltd., 725 Moo 4, Tambol Banklang, Amphur Muagn, Lamphun 5100, Thailand. HOYA Lamphun Ltd. processes will be limited to machining, polishing, inspecting, assembly, and primary packaging (pre-sterilization) of intraocular lenses (IOLs) and injector cartridges.

Current openFDA PMA Record#

Device: iSert Preloaded System
Applicant: Hoya Surgical Optics, Inc.
PMA number: P080004
Supplement: S031
Product code: HQL
Generic name: intraocular lens
Decision date: 2021-05-21
Decision code: APPR
Date received: 2020-01-30
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 HOYA Lamphun Ltd., 725 Moo 4, Tambol Banklang, Amphur Muagn, Lamphun 5100, Thailand. HOYA Lamphun Ltd. processes will be limited to machining, polishing, inspecting, assembly, and primary packaging (pre-sterilization) of intraocular lenses (IOLs) and injector cartridges.