PMA P210005S011

Device: IC-8 Apthera Intraocular Lens (IOL)
Applicant: Acu Focus, Inc.
PMA number: P210005
Supplement: S011
Product code: POE
Decision date: 2025-08-04
Classification: Ophthalmic
Generic name: Extended depth of focus intraocular lens
Approval order statement: approval for a change to the address block of your labeling for the IC-8 Apthera IOL to align with other IOLs in the Bausch & Lomb portfolio

Current openFDA PMA Record#

Device: IC-8 Apthera Intraocular Lens (IOL)
Applicant: Acu Focus, Inc.
PMA number: P210005
Supplement: S011
Product code: POE
Generic name: Extended depth of focus intraocular lens
Decision date: 2025-08-04
Decision code: APPR
Date received: 2025-07-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change to the address block of your labeling for the IC-8 Apthera IOL to align with other IOLs in the Bausch & Lomb portfolio