Iolmaster

• 2 recalls, same reason

  • Terminated Z-0358-2016 FDA Class II ·initiated 27 Oct 2015
  • Terminated Z-0357-2016 FDA Class II ·initiated 27 Oct 2015

  IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

• 2 recalls, same reason

  • Terminated Z-0333-2014 FDA Class II ·initiated 23 Oct 2013
  • Terminated Z-0334-2014 FDA Class II ·initiated 23 Oct 2013

  The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.

510(k) Number

K993357 ↗

FDA Product Code

HJO

Device Class

Class II

Regulation

21 CFR Part 886.1850

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• S 21 Instrument Stand

  Class I

  FDA 510(k) K883578 Active Cleared 13 Sep 1988

• Zeiss Multiyag Laser

  Class II

  FDA 510(k) K920529 Active Cleared 2 Apr 1992

• Zeiss 20 Sl Slit-Lamp & Mechanical Micromanipulatr

  Class II

  FDA 510(k) K925641 Active Cleared 9 Sep 1993

• S 22 Instrument Stand

  Class I

  FDA 510(k) K891584 Active Cleared 8 Jun 1989

• Opmi Twiner Surgical Microscope

  Class II

  FDA 510(k) K983868 Active Cleared 29 Jan 1999

• Zeiss Laser Indirect Ophthalmoscope

  Class II

  FDA 510(k) K924588 Active Cleared 9 Jul 1993

See all devices from Carl Zeiss, Inc. →