PMA P930014S137

Device
AcrySof Posterior Chamber Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S137
Product code
HQL
Decision date
2021-07-14
Generic name
intraocular lens
Approval order statement
Remove constant T microvacuole testing as release criteria for Alcon AcrySof® and AcrySof® IQ ReSTOR® intraocular lenses.

Current openFDA PMA Record#

Device
AcrySof Posterior Chamber Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S137
Product code
HQL
Generic name
intraocular lens
Decision date
2021-07-14
Decision code
OK30
Date received
2021-06-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Remove constant T microvacuole testing as release criteria for Alcon AcrySof® and AcrySof® IQ ReSTOR® intraocular lenses.