Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph

FDA Premarket Approval P190018 S009

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 to expand dioptric-power range to 6. 0 d - 34. 0 d for clareon panoptix trifocal hydrophobic iol (cnwtt0), clareon panoptix trifocal uv absorbing iol (ccwtt0), and clareon panoptix trifocal hydrophobic iol models cnwtt3-cnwtt6, as well as approval for clareon panoptix toric trifocal hydrophobic iol with the autonome automated preloaded delivery device (cnatt3-cnatt6)

DeviceClareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph
Generic NameLens, Multifocal Intraocular
ApplicantAlcon Research, Ltd.
Date Received2020-12-14
Decision Date2021-03-15
PMAP190018
SupplementS009
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Research, Ltd. 6201 South Freeway, Tc-467 forth Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P190018Original Filing
S009 2020-12-14 Real-time Process
S008 2020-10-30 30-day Notice
S007 2020-10-16 30-day Notice
S006 2020-08-31 30-day Notice
S005
S004 2020-05-19 30-day Notice
S003
S002
S001

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