AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

FDA Premarket Approval P060022 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the removal of verbiage pertaining to the clinical assessment of the addition of the aspheric surface.

DeviceAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received2011-02-16
Decision Date2011-10-21
PMAP060022
SupplementS010
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P060022Original Filing
S030 2022-08-16 30-day Notice
S029 2021-12-22 30-day Notice
S028 2020-12-04 30-day Notice
S027
S026
S025 2019-12-23 30-day Notice
S024 2018-07-10 30-day Notice
S023 2016-06-03 30-day Notice
S022 2015-09-11 135 Review Track For 30-day Notice
S021 2015-02-18 30-day Notice
S020 2014-12-08 Real-time Process
S019 2014-05-15 30-day Notice
S018
S017 2013-06-10 30-day Notice
S016 2013-04-15 Real-time Process
S015 2013-02-22 30-day Notice
S014 2012-08-20 30-day Notice
S013 2012-03-20 Real-time Process
S012 2011-06-21 Normal 180 Day Track
S011 2011-05-09 30-day Notice
S010 2011-02-16 Normal 180 Day Track No User Fee
S009 2011-03-18 30-day Notice
S008 2011-03-18 135 Review Track For 30-day Notice
S007 2010-04-30 30-day Notice
S006 2010-01-29 Real-time Process
S005 2009-08-25 30-day Notice
S004 2009-03-06 30-day Notice
S003
S002 2008-10-24 Real-time Process
S001 2008-10-20 30-day Notice

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