PMA P190018S054

Device
Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S054
Product code
HQL
Decision date
2026-07-02
Classification
Ophthalmic
Generic name
intraocular lens
Approval order statement
approval of ECH residual test method change at Alcon Research, LLC, WV USA

Current openFDA PMA Record#

Device
Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S054
Product code
HQL
Generic name
intraocular lens
Decision date
2026-07-02
Decision code
OK30
Date received
2026-06-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval of ECH residual test method change at Alcon Research, LLC, WV USA