PMA P960028S004

Device
AMO ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL)
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P960028
Supplement
S004
Product code
MFK
Decision date
1999-06-08
Generic name
Lens, multifocal intraocular
Approval order statement
Approval to expand the diopter range of the ARRAY(R) IOL from 16-24D to 6-30D in half diopter increments.

Current openFDA PMA Record#

Device
AMO ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL)
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P960028
Supplement
S004
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
1999-06-08
Decision code
APPR
Date received
1998-10-23
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to expand the diopter range of the ARRAY(R) IOL from 16-24D to 6-30D in half diopter increments.