PMA P080004S034

Device: iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL)
Applicant: Hoya Surgical Optics, Inc.
PMA number: P080004
Supplement: S034
Product code: HQL
Decision date: 2020-06-15
Generic name: intraocular lens
Approval order statement: Approval for two new IOL models, iSert® models 254 and 255 which are minor modifications of approved parent preloaded IOL iSert® Model 251.

Current openFDA PMA Record#

Device: iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL)
Applicant: Hoya Surgical Optics, Inc.
PMA number: P080004
Supplement: S034
Product code: HQL
Generic name: intraocular lens
Decision date: 2020-06-15
Decision code: APPR
Date received: 2020-03-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for two new IOL models, iSert® models 254 and 255 which are minor modifications of approved parent preloaded IOL iSert® Model 251.