PMA P880090S030

Device
PMMA Anterior Chamber Intraocular Lenses
Applicant
Bausch & Lomb, Inc.
PMA number
P880090
Supplement
S030
Product code
HQL
Decision date
2019-02-28
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and PMMA intraocular lenses be transferred to a new testing laboratory.

Current openFDA PMA Record#

Device
PMMA Anterior Chamber Intraocular Lenses
Applicant
Bausch & Lomb, Inc.
PMA number
P880090
Supplement
S030
Product code
HQL
Generic name
intraocular lens
Decision date
2019-02-28
Decision code
OK30
Date received
2019-01-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and PMMA intraocular lenses be transferred to a new testing laboratory.