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PMA P910056S030

Device
Enhanced enVista Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S030
Product code
HQL
Decision date
2018-07-10
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Modification of the extraction process from single manual extraction to bulk extraction for the enVista® Hydrophobic Acrylic Intraocular Lens, Model MX60E.

Current openFDA PMA Record#

Device
Enhanced enVista Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S030
Product code
HQL
Generic name
intraocular lens
Decision date
2018-07-10
Decision code
OK30
Date received
2018-06-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification of the extraction process from single manual extraction to bulk extraction for the enVista® Hydrophobic Acrylic Intraocular Lens, Model MX60E.