PMA P030016

Device: The EVO/EVO+ Visian Implantable Collamer Lens (ICL)
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S043
Product code: MTA
Decision date: 2026-03-04
Generic name: Lens, intraocular, phakic
Approval order statement: a software update to the optical metrology system used in the production of EVO/EVO+ Visian and Visian Toric Implantable Collamer® Lenses to incorporate lens size and lens model identification inspection capabilities, in addition to the existing dioptric power and image quality measurement functions.

Current openFDA PMA Record#

Device: The EVO/EVO+ Visian Implantable Collamer Lens (ICL)
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S051
Product code: MTA
Generic name: Lens, intraocular, phakic
Decision date: 2026-03-04
Decision code: APPR
Date received: 2025-09-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a software update to the optical metrology system used in the production of EVO/EVO+ Visian and Visian Toric Implantable Collamer® Lenses to incorporate lens size and lens model identification inspection capabilities, in addition to the existing dioptric power and image quality measurement functions.