PMA P080004S015

Device

ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)

Applicant

Hoya Surgical Optics, Inc.

PMA number

P080004

Supplement

S015

Product code

HQL

Decision date

2014-06-16

Classification

Intraocular Lens

Generic name

intraocular lens

Approval order statement

APPROVAL FOR AN OPTICAL DESIGN CURVATURE MODIFICATION TO THE ISERT® MODEL 251 TO ADD A CONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC MODEL 751 AND IS INDICATEDFOR IMPLANTATION AFTER EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION OF CATARACTS IN ADULTS. THIS LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.

Summary

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