PMA P190018

Device
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S021
Product code
HQL
Decision date
2026-07-06
Generic name
intraocular lens
Approval order statement
A new model of spin rinse dryer for the cleaning process for AcrySof ReSTOR, Clareon, Clareon Toric, and AcrySof Posterior Chamber IOLs

Current openFDA PMA Record#

Device
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S053
Product code
HQL
Generic name
intraocular lens
Decision date
2026-07-06
Decision code
OK30
Date received
2026-06-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
A new model of spin rinse dryer for the cleaning process for AcrySof ReSTOR, Clareon, Clareon Toric, and AcrySof Posterior Chamber IOLs