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 ID: 00813359021103
• NIH Device Record Key: ba5159a4-a74e-47d9-b58f-3bf892bfb19a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IC-8 Apthera IOL
• Version Model Number: +28.5 D
• Catalog Number: 82078-285
• Company DUNS: 138585281
• Company Name: ACUFOCUS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813359021103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210005

FDA Product Code

• POE: Extended Depth Of Focus Intraocular Lens

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [IC-8 Apthera IOL]

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