PMA P030016S049

Device: Visian® Toric Implantable Collamer® Lens (TICL)
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S049
Product code: QCB
Decision date: 2025-12-10
Classification: Ophthalmic
Generic name: Phakic toric intraocular lens
Approval order statement: Approval for updates to labeling for the Visian® Toric Implantable Collamer Lens (TICL)™, EVO/EVO+ Visian® ICL™, and EVO/EVO+ Visian® TICL™ to reflect the findings of the P030016/S001 PMA New Enrollment Post-Approval Study.

Current openFDA PMA Record#

Device: Visian® Toric Implantable Collamer® Lens (TICL)
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S049
Product code: QCB
Generic name: Phakic toric intraocular lens
Decision date: 2025-12-10
Decision code: APPR
Date received: 2025-06-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for updates to labeling for the Visian® Toric Implantable Collamer Lens (TICL)™, EVO/EVO+ Visian® ICL™, and EVO/EVO+ Visian® TICL™ to reflect the findings of the P030016/S001 PMA New Enrollment Post-Approval Study.