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Ideal Optics, Inc.

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Ideal Optics, Inc. makes

Ideal Optics, Inc. manufactures SOFTICS™ (POLYMACON), a soft contact lens designed for corneal reshaping therapy to correct myopia and related refractive errors. These lenses are intended for overnight wear to gradually reshape the cornea during sleep, providing clear vision during waking hours without the need for corrective lenses.

The company’s products fall under FDA Class II devices and are listed under a Premarket Approval (PMA) application. SOFTICS™ is regulated under the US Food and Drug Administration’s regulatory framework, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Softics(Tm) (Polymacon) Ref P830012

    Active Regimes: PMA Registry: PMA Class:II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Ideal Optics, Inc., initiated on 2004-10-12. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 12 Oct 2004 Z-0221-05 Unclassified (pre-2012) Terminated Lenses may not be sterile. Distribution: AL, GA, NC, NY, SC, VA

Frequently asked questions

How many devices does Ideal Optics, Inc. have in the registry?

The registry currently lists 1 device for Ideal Optics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ideal Optics, Inc.'s devices?

Among its 1 most recently registered device, Ideal Optics, Inc. has devices listed in FDA PMA (1 device).

What risk classes do Ideal Optics, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Ideal Optics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ideal Optics, Inc.?

FDA recall records list 1 recall initiated by Ideal Optics, Inc., the most recent initiated on 12 Oct 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Ideal Optics, Inc. in the registry?

The most recently registered devices listed for Ideal Optics, Inc. include SOFTICS(TM) (POLYMACON).

Generated automatically from registry data and not verified by a human reviewer.