AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens, Models MA60D3 and SA60D3

• 2 recalls, same reason

  • Terminated Z-0429-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006
  • Terminated Z-0430-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006

  Intraocular lenses exposed to extreme temperatures while in storage.

Full name

AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens

Trade Name

Acrysof Restor Apodized Diffractive Optic Posterior Chamber IOL

Generic Name

Lens, multifocal intraocular

PMA Number

P040020 ↗

FDA Product Code

MFK

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

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See all devices from Alcon Research, Ltd. →

• What types of vision correction does this intraocular lens provide, and who is it intended for?

  The AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens is designed to correct aphakia (the absence of a natural lens) after cataract removal in adult patients. It offers multifocal vision correction, enabling clear vision at near, intermediate, and distance ranges while increasing spectacle independence. This makes it ideal for patients who desire reduced reliance on glasses for various activities.

• How is this lens supplied, and is it reusable?

  The AcrySof IQ ReSTOR lens is supplied sterile and is explicitly intended for single-use only. This ensures patient safety and reduces the risk of infection or contamination during surgical procedures.

• What model references should I look for when ordering this device?

  This lens is available under specific model references: MA60D3 and SA60D3. These identifiers help ensure you select the correct lens for your surgical needs, as they are tailored for precise placement within the capsular bag.

• What regulatory pathway was followed for this device, and how does that affect its use?

  The AcrySof IQ ReSTOR lens underwent a Premarket Approval (PMA) process through the FDA, as it is classified as a Class III medical device. This rigorous review confirms its safety and effectiveness for the intended use—correcting aphakia with multifocal vision correction—ensuring compliance with strict regulatory standards before clinical use.