PMA P910056S026

Device
enVista Hydrophobic Acrylic Intraocular Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S026
Product code
HQL
Decision date
2017-11-01
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Change to the method of manufacturing the enVista Hydrophobic Acrylic IOL Model MX60.

Current openFDA PMA Record#

Device
enVista Hydrophobic Acrylic Intraocular Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S026
Product code
HQL
Generic name
intraocular lens
Decision date
2017-11-01
Decision code
OK30
Date received
2017-10-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the method of manufacturing the enVista Hydrophobic Acrylic IOL Model MX60.