PMA P090022S001

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S001
Product code: HQL
Decision date: 2010-06-17
Generic name: intraocular lens
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE OPTIC DESIGN OF THE SOFTEC HD LENS TO INTRODUCE BI-SPHERIC OPTIC SURFACES AND CHANGES TO THE LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC I AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG REPLACEMENT.

Current openFDA PMA Record#

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S001
Product code: HQL
Generic name: intraocular lens
Decision date: 2010-06-17
Decision code: APPR
Date received: 2010-05-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE OPTIC DESIGN OF THE SOFTEC HD LENS TO INTRODUCE BI-SPHERIC OPTIC SURFACES AND CHANGES TO THE LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC I AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG REPLACEMENT.