IC-8 Apthera IOL 82078-285

GUDID 00813359021103

One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.

ACUFOCUS, INC.

Posterior-chamber intraocular lens, pseudophakic, extended-focus
Primary Device ID00813359021103
NIH Device Record Keyba5159a4-a74e-47d9-b58f-3bf892bfb19a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIC-8 Apthera IOL
Version Model Number+28.5 D
Catalog Number82078-285
Company DUNS138585281
Company NameACUFOCUS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813359021103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

POEExtended Depth Of Focus Intraocular Lens

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-12
Device Publish Date2023-01-04

On-Brand Devices [IC-8 Apthera IOL]

00813359021134One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021127One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021110One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021103One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021097One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021080One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021073One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021066One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021059One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021042One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021035One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021028One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021011One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359021004One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020991One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020984One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020977One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020960One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020953One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020946One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020939One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020922One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020915One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020908One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020892One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020885One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020878One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020861One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020854One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020847One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020830One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020823One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020816One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020809One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020793One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020786One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020779One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020762One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020755One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020748One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
00813359020731One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.

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