PMA P080004S012

Device

ISERT MODEL PC-60AD PACKAGING IMPROVEMENT

Applicant

Hoya Surgical Optics, Inc.

PMA number

P080004

Supplement

S012

Product code

HQL

Decision date

2012-07-17

Classification

Intraocular Lens

Generic name

intraocular lens

Approval order statement

APPROVAL FOR A PACKAGING CONFIGURATION CHANGE FOR THE ISERT MODEL PC-60AD INTRAOCULAR LENS (IOL). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT MODEL 230 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

<a href="#main" target="_new">Quick Links: Skip to main page content</a> <a href="#search_form" target="_new">Skip to Search</a> <a href="#fda-topmenu-home" target="_new">Skip to Topics Menu</a> <a href="#footer" target="_new">Skip to Common Links</a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_small.png" alt="Decrease font size" title="Decrease font size"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_medium.png" alt="Return font size to normal" title="Return font size to normal"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_large.png" alt="Increase font size" title="Increase font size"/></a> <a href="http://www.hhs.gov/" target="_new"><img id="rrimg1" border="0" src="/scripts/includes/images/img_fdagov_hhs_masthead_logo_r.png" alt="U.S. Department of Health and Human Services" title="U.S. Department of Health and Human Services"/></a> <a href="https://www.fda.gov/" target="_new"><img src="/scripts/includes/images/gov-fda-new-white.png" alt="FDA, U.S. Food and Drug Administration" border="0" title="FDA, U.S. Food and Drug Administration"/></a> <a href="https://www.fda.gov/news-events/interactive-media" target="_new">Follow FDA</a> <a href="https://www.fda.gov/about-fda/fda-en-espanol" target="_new">En Espa&ntilde;ol</a> <a href="javascript:document.getElementById('search_form').submit();" target="_new"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"/></a> <a href="https://www.fda.gov/" target="_new"><span>Home</span></a> <a href="https://www.fda.gov/food" target="_new"><span>Food</span></a> <a href="https://www.fda.gov/Drugs" target="_new"><span>Drugs</span></a> <a href="https://www.fda.gov/Medical-Devices" target="_new"><span>Medical Devices</span></a> <a href="https://www.fda.gov/radiation-emitting-products" target="_new"><span>Radiation-Emitting Products</span></a> <a href="https://www.fda.gov/vaccines-blood-biologics" target="_new"><span>Vaccines, Blood &amp; Biologics</span></a> <a href="https://www.fda.gov/animal-veterinary" target="_new"><span>Animal &amp; Veterinary</span></a> <a href="https://www.fda.gov/cosmetics" target="_new"><span>Cosmetics</span></a> <a href="https://www.fda.gov/tobacco-products" target="_new"><span>Tobacco Products</span></a> <a href="javascript:window.print();" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_print.png" alt="Print" title="Print this page"/></a> <a href="http://www.addthis.com/bookmark.php?u508=true&v=152&amp;username=fdamain" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_share.png" alt="Share" title="Share this page"/></a> <a href="http://www.addthis.com/bookmark.php" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_email.png" alt="E-mail" title="E-mail this page"/></a> <a href="https://www.fda.gov/" target="_new">FDA Home</a> <a href="http://www.fda.gov/MedicalDevices/default.htm" target="_new">Medical Devices</a> <a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm" target="_new">Databases</a> <a href="/scripts/cdrh/devicesatfda/index.cfm" target="_new"><img src="../images/supersearch.gif" align="left" border="0" alt="Super Search Devices@FDA"></a>