PMA P990013S034

Device: COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S034
Product code: HQL
Decision date: 2017-04-06
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Modify the hydration step for the Collamer IOL Models CQ2015A and CC4204A and to remove the cometic inspection step for the Collamer IOL Model CC4204A that was performed as part of the hydration process.

Current openFDA PMA Record#

Device: COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S034
Product code: HQL
Generic name: intraocular lens
Decision date: 2017-04-06
Decision code: OK30
Date received: 2017-03-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the hydration step for the Collamer IOL Models CQ2015A and CC4204A and to remove the cometic inspection step for the Collamer IOL Model CC4204A that was performed as part of the hydration process.