PMA P990013S036

Device: Collamer UV Absorbing Posterior Chamber Three and One Piece Foldable Intraocular LEns
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S036
Product code: HQL
Decision date: 2017-08-02
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Add an alternate instrument to measure the optical properties of the Collamer IOL at the Monrovia, California facility.

Current openFDA PMA Record#

Device: Collamer UV Absorbing Posterior Chamber Three and One Piece Foldable Intraocular LEns
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S036
Product code: HQL
Generic name: intraocular lens
Decision date: 2017-08-02
Decision code: OK30
Date received: 2017-07-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an alternate instrument to measure the optical properties of the Collamer IOL at the Monrovia, California facility.