PMA P210005S005

Device: IC-8 Apthera Intraocular Lens
Applicant: Acu Focus, Inc.
PMA number: P210005
Supplement: S005
Product code: POE
Decision date: 2023-07-31
Classification: Ophthalmic
Generic name: Extended depth of focus intraocular lens
Approval order statement: Approval for a manufacturing site located at Bausch & Lomb, 21 N. Park Place Blvd., Clearwater, Florida, 33759 for the following functions: 1) Receiving inspections of device raw materials/ subassemblies 2) Shipping and handling of device raw materials/subassemblies 3) Lot release and documentation review of finished devices 4) Handling, storage, preservation and distribution of finished devices.

Current openFDA PMA Record#

Device: IC-8 Apthera Intraocular Lens
Applicant: Acu Focus, Inc.
PMA number: P210005
Supplement: S005
Product code: POE
Generic name: Extended depth of focus intraocular lens
Decision date: 2023-07-31
Decision code: APPR
Date received: 2023-06-01
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 Bausch & Lomb, 21 N. Park Place Blvd., Clearwater, Florida, 33759 for the following functions: 1) Receiving inspections of device raw materials/ subassemblies 2) Shipping and handling of device raw materials/subassemblies 3) Lot release and documentation review of finished devices 4) Handling, storage, preservation and distribution of finished devices.