PMA P210005S003

Device: IC-8® Apthera™ Intraocular Lens (IOL)
Applicant: Acu Focus, Inc.
Product code: POE
Decision date: 2022-12-23
Generic name: Extended depth of focus intraocular lens
Approval order statement: Approval for the extension of the expiration dating on product labeling from 6 months to 12 months, and proposed modifications to the protocols for your respective ongoing accelerated and real-time shelf life studies.

Current openFDA PMA Record#

Device: IC-8® Apthera™ Intraocular Lens (IOL)
Applicant: Acu Focus, Inc.
PMA number: P210005
Supplement: S003
Product code: POE
Generic name: Extended depth of focus intraocular lens
Decision date: 2022-12-23
Decision code: APPR
Date received: 2022-09-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the extension of the expiration dating on product labeling from 6 months to 12 months, and proposed modifications to the protocols for your respective ongoing accelerated and real-time shelf life studies.