PMA P030016S033

Device: Visian Implantable Collamer Lens for Myopia
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S033
Product code: MTA
Decision date: 2017-08-04
Classification: Lens, Intraocular, Phakic
Generic name: Lens, intraocular, phakic
Approval order statement: Addition of an autoclave for use in the sterilization of the Visian Implantable Collamer Lens (ICL) and the Collamer Intraocular Lens (CIOL) at the Monrovia, California facility.

Current openFDA PMA Record#

Device: Visian Implantable Collamer Lens for Myopia
Applicant: STAAR Surgical Company
PMA number: P030016
Supplement: S033
Product code: MTA
Generic name: Lens, intraocular, phakic
Decision date: 2017-08-04
Decision code: OK30
Date received: 2017-07-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an autoclave for use in the sterilization of the Visian Implantable Collamer Lens (ICL) and the Collamer Intraocular Lens (CIOL) at the Monrovia, California facility.