PMA P030016S047

Device: EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S047
Product code: MTA
Decision date: 2025-03-05
Classification: Ophthalmic
Generic name: Lens, intraocular, phakic
Approval order statement: Approval for modification to the labeling for the EVO/EVO+ VISIAN® Implantable CollamerTM Lens for Myopia and EVO/EVO+ VISIAN® TORIC Implantable CollamerTM Lens for Myopia to reflect the findings of the P030016/S035 PMA cohort follow-up Post-approval Study.

Current openFDA PMA Record#

Device: EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S047
Product code: MTA
Generic name: Lens, intraocular, phakic
Decision date: 2025-03-05
Decision code: APPR
Date received: 2024-09-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for modification to the labeling for the EVO/EVO+ VISIAN® Implantable CollamerTM Lens for Myopia and EVO/EVO+ VISIAN® TORIC Implantable CollamerTM Lens for Myopia to reflect the findings of the P030016/S035 PMA cohort follow-up Post-approval Study.