Device (U260 +5 more) - U365

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Model 304 (Ultra C-Loop)

Generic Name

intraocular lens

PMA Number

P860059 ↗

FDA Product Code

HQL

Models / Variants

U260

U360

U360N

U365

U370

UP383 Lenses

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

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• The Amo Ophthalmic Surgical System

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• Lens Plus Rewetting Drops

  Class II

  FDA 510(k) K042562 Active Cleared 29 Jul 2005

• Vitrectomy Cutter and Accessories

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  FDA 510(k) K081681 Active Cleared 8 Oct 2008

• Blink Cl Lubricant Eye Drops

  Class II

  FDA 510(k) K032030 Active Cleared 25 Sep 2003

• One Series Ultra Cartridge, Model 1VIPR30

  Class I

  FDA 510(k) K081545 Active Cleared 2 Oct 2008

See all devices from Advanced Medical Optics, Inc. →