C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens

FDA Premarket Approval P060011 S024

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

An alternative supplier of 0. 9% w/v sodium chloride, new tubing for controlled dosing of saline, and a new desktop autoclave for sterilization of new tubing

DeviceC-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens
Generic NameIntraocular Lens
ApplicantRAYNER INTRAOCULAR LENSES LTD.
Date Received2020-05-26
Decision Date2020-06-24
PMAP060011
SupplementS024
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address RAYNER INTRAOCULAR LENSES LTD. 1-2 Sackville Trading Estate, sackville Road hove, East Sussex BN3 7

Supplemental Filings

Supplement NumberDateSupplement Type
P060011Original Filing
S024 2020-05-26 30-day Notice
S023
S022 2020-05-11 30-day Notice
S021 2020-04-27 30-day Notice
S020 2020-03-02 30-day Notice
S019 2020-01-27 30-day Notice
S018 2019-07-01 30-day Notice
S017 2019-03-20 30-day Notice
S016 2019-03-01 30-day Notice
S015
S014 2018-04-02 Normal 180 Day Track
S013 2017-11-13 30-day Notice
S012 2017-07-03 Normal 180 Day Track No User Fee
S011 2017-04-21 30-day Notice
S010 2016-08-01 30-day Notice
S009 2016-05-09 30-day Notice
S008 2015-08-13 30-day Notice
S007 2015-06-05 135 Review Track For 30-day Notice
S006 2015-03-13 30-day Notice
S005 2015-02-02 Real-time Process
S004 2012-05-29 Real-time Process
S003 2012-02-06 30-day Notice
S002 2011-09-13 Real-time Process
S001 2011-02-28 30-day Notice

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