PMA P080004S030

Device: IPure Preloaded IOL System
Applicant: Hoya Surgical Optics, Inc.
Product code: HQL
Decision date: 2020-04-17
Generic name: intraocular lens
Approval order statement: Approval for packaging changes for the iSert® Preloaded System Platform Models 250 and 251. This device, as modified, will be marketed under the tradename IPure Preloaded System Platform Models B1PC and B1PY and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.

Current openFDA PMA Record#

Device: IPure Preloaded IOL System
Applicant: Hoya Surgical Optics, Inc.
PMA number: P080004
Supplement: S030
Product code: HQL
Generic name: intraocular lens
Decision date: 2020-04-17
Decision code: APPR
Date received: 2019-12-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for packaging changes for the iSert® Preloaded System Platform Models 250 and 251. This device, as modified, will be marketed under the tradename IPure Preloaded System Platform Models B1PC and B1PY and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.