PMA P990013S037

Device: Collamer UV Absorbing Posterior Chamber Intraocular Lens
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S037
Product code: HQL
Decision date: 2017-08-04
Classification: Intraocular Lens
Generic name: intraocular lens
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: Collamer UV Absorbing Posterior Chamber Intraocular Lens
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S037
Product code: HQL
Generic name: intraocular lens
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.