PMA P090022S022

Device: SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S022
Product code: HQL
Decision date: 2014-06-16
Generic name: intraocular lens
Approval order statement: APPROVAL TO REDUCE THE SIZE OF THE SECONDARY PACKAGING WHICH HOUSES THE POUCHED INTRAOCULAR LENSES, LABEL AND DIRECTIONS FOR USE (DFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD, SOFTEC I, AND SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATON CATARACT REMOVAL INADULTS OVER THE AGE OF 21.

Current openFDA PMA Record#

Device: SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S022
Product code: HQL
Generic name: intraocular lens
Decision date: 2014-06-16
Decision code: APPR
Date received: 2014-05-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO REDUCE THE SIZE OF THE SECONDARY PACKAGING WHICH HOUSES THE POUCHED INTRAOCULAR LENSES, LABEL AND DIRECTIONS FOR USE (DFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD, SOFTEC I, AND SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATON CATARACT REMOVAL INADULTS OVER THE AGE OF 21.