PMA P190018S047

Device
Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S047
Product code
HQL
Decision date
2026-02-19
Classification
Ophthalmic
Generic name
intraocular lens
Approval order statement
Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon TruPlus Toric Aspheric Hydrophobic Acrylic IOL, Clareon TruPlus Aspheric UV Absorbing IOL, and Clareon TruPlus Toric Aspheric UV Absorbing IOL in both lens case and AutonoMe Pre-loaded Delivery System configurations

Current openFDA PMA Record#

Device
Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S047
Product code
HQL
Generic name
intraocular lens
Decision date
2026-02-19
Decision code
APPR
Date received
2025-11-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon TruPlus Toric Aspheric Hydrophobic Acrylic IOL, Clareon TruPlus Aspheric UV Absorbing IOL, and Clareon TruPlus Toric Aspheric UV Absorbing IOL in both lens case and AutonoMe Pre-loaded Delivery System configurations