Model UV65 Series Anterior Chamber Intraocular Lenses

• • Terminated Z-0097-06 FDA Unclassified (pre-2012) ·initiated 5 Oct 2005

  A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.

Full name

Model UV65 Series Anterior Chamber Lenses

Trade Name

Model UV65 Anterior Chamber Intraocular Lens

Generic Name

intraocular lens

PMA Number

P880070 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

• Sovereign Compact Phacoemulsification System

  Class II

  FDA 510(k) K111446 Active Cleared 21 Dec 2011

• Dual Pump Pack Open recall

  Class II

  FDA 510(k) K160236 Active Cleared 27 Apr 2016

• Laminar Flow Phaco Tips

  Class II

  FDA 510(k) K111882 Active Cleared 7 Nov 2011

• Unit, Phacofragmentation

  Class II

  FDA 510(k) K103023 Active Cleared 1 Jun 2011

• Amo Whitestar Signature Phacoemulsification System

  Class II

  FDA 510(k) K111697 Active Cleared 27 Sep 2011

• Catalys Precision Laser System

  Class II

  FDA 510(k) K170322 Active Cleared 19 May 2017

See all devices from Abbott Medical Optics, Inc. →