PMA P910056S031

Device
enVista Hydrophobic Arcylic Intraocular Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S031
Product code
HQL
Decision date
2018-08-06
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Modification of the lens holder internal surface finish for the enVista One Piece Hydrophobic Acrylic Intraocular Lens, Models MX60 and MX60T.

Current openFDA PMA Record#

Device
enVista Hydrophobic Arcylic Intraocular Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S031
Product code
HQL
Generic name
intraocular lens
Decision date
2018-08-06
Decision code
OK30
Date received
2018-07-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification of the lens holder internal surface finish for the enVista One Piece Hydrophobic Acrylic Intraocular Lens, Models MX60 and MX60T.