PMA P090022S004

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S004
Product code: HQL
Decision date: 2011-02-02
Generic name: intraocular lens
Approval order statement: APPROVAL TO EXTEND THE POWER RANGE FOR WHICH LENSES ARE MARKETED IN 1/4 DIOPTER INCREMENT FROM 18.0 THROUGH 25.0 DIOPTERS TO 15.0 THROUGH 25.0 DIOPTERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD PS POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) 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 PLACEMENT.

Current openFDA PMA Record#

Device: SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S004
Product code: HQL
Generic name: intraocular lens
Decision date: 2011-02-02
Decision code: APPR
Date received: 2010-12-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO EXTEND THE POWER RANGE FOR WHICH LENSES ARE MARKETED IN 1/4 DIOPTER INCREMENT FROM 18.0 THROUGH 25.0 DIOPTERS TO 15.0 THROUGH 25.0 DIOPTERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD PS POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) 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 PLACEMENT.