PMA P090022S011

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S011
Product code: HQL
Decision date: 2012-06-11
Generic name: intraocular lens
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE OPTIC BODY SHAPE AND OVERALLDIAMETER OF YOUR SOFTEC HD LENS TO INTRODUCE A LENS WITH AN OVOID OPTIC AND OVERALL DIAMETER OF 12.50 MM AND CHANGES TO YOUR LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICA- TION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG PLACEMENT.

Current openFDA PMA Record#

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S011
Product code: HQL
Generic name: intraocular lens
Decision date: 2012-06-11
Decision code: APPR
Date received: 2012-03-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE OPTIC BODY SHAPE AND OVERALLDIAMETER OF YOUR SOFTEC HD LENS TO INTRODUCE A LENS WITH AN OVOID OPTIC AND OVERALL DIAMETER OF 12.50 MM AND CHANGES TO YOUR LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICA- TION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG PLACEMENT.