PMA P080004S013

Device

ISERT GEMETRIC

Applicant

Hoya Surgical Optics, Inc.

PMA number

P080004

Supplement

S013

Product code

HQL

Decision date

2013-03-13

Classification

Intraocular Lens

Generic name

intraocular lens

Approval order statement

APPROVAL FOR THE MODEL 731 INTRAOCULAR LENS (IOL), WHICH ADDS ACONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC¿ AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.

Summary

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