PMA P030016S037

Device: Visian ICL Implantable Collamer Lens (ICL)
Applicant: STAAR Surgical Company
Product code: MTA
Decision date: 2019-07-19
Generic name: Lens, intraocular, phakic
Approval order statement: Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).

Current openFDA PMA Record#

Device: Visian ICL Implantable Collamer Lens (ICL)
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S037
Product code: MTA
Generic name: Lens, intraocular, phakic
Decision date: 2019-07-19
Decision code: APPR
Date received: 2019-04-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).