Alcon Vision System

• 11 recalls, same reason

  • Terminated Z-1929-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1925-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1934-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1931-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1927-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1930-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1924-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1932-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1926-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1928-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010
  • Terminated Z-1933-2010 FDA Unclassified (pre-2012) ·initiated 30 Apr 2010

  Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.

510(k) Number

K063583 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Opti-Free Express Multi-Purpose Solution

  Class II

  FDA 510(k) K981574 Active Cleared 6 Jul 1998

• Inteliport Occluding Device

  Unclassified

  FDA 510(k) K040231 Active Cleared 13 Jul 2004

• Soft (Hydrophilic) Contact Lens Care Solution

  Class II

  FDA 510(k) K031193 Active Cleared 3 Jul 2003

• Alcon Multi-Purpose Solution

  Class II

  FDA 510(k) K071236 Active Cleared 12 Dec 2007

• Models 1S & 1P Intraocular Lens

  Class III

  FDA PMA P800049 Active Approved 31 Mar 1983

• Zirconia Silicate Bead IOL Tumble Polishing

  Class III

  FDA PMA P820035 Withdrawn Approved 28 Feb 1986

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