PMA P030002S040

Device: Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S040
Product code: NAA
Decision date: 2022-01-19
Generic name: Lens, intraocular, accommodative
Approval order statement: Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.

Current openFDA PMA Record#

Device: Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S040
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2022-01-19
Decision code: OK30
Date received: 2021-12-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.