PMA P090022S031

Device
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S031
Product code
HQL
Decision date
2017-02-07
Generic name
intraocular lens
Approval order statement
Revision of the final cleaning process step in the manufacture of intraocular lenses.

Current openFDA PMA Record#

Device
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S031
Product code
HQL
Generic name
intraocular lens
Decision date
2017-02-07
Decision code
OK30
Date received
2017-01-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Revision of the final cleaning process step in the manufacture of intraocular lenses.