PMA P080004S026

Device
iSymm, iSpheric IOL
Applicant
Hoya Surgical Optics, Inc.
PMA number
P080004
Supplement
S026
Product code
HQL
Decision date
2019-12-04
Generic name
intraocular lens
Approval order statement
Change to the supplier of the lens case for non-preloaded IOLs.

Current openFDA PMA Record#

Device
iSymm, iSpheric IOL
Applicant
Hoya Surgical Optics, Inc.
PMA number
P080004
Supplement
S026
Product code
HQL
Generic name
intraocular lens
Decision date
2019-12-04
Decision code
OK30
Date received
2019-11-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the supplier of the lens case for non-preloaded IOLs.