The Recall Desk

FDA (Devices) recall action 66635

Carl Zeiss Meditec, Inc. recalled 2 products on 2013-11-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-27
Critical
0
Units
6,108

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2013-11-27

    Zeiss IOLMaster 500 Recalled for Erroneous Lens Database Value

    Carl Zeiss Meditec is recalling 1,201 IOLMaster 500 devices because an incorrect database value for the AMO Sensar AR40E lens could lead to the implantation of lenses with the wrong diopter.

    Product
    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use prima
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-11-27

    Zeiss IOLMaster Recalled for Incorrect Lens Database Value

    Carl Zeiss Meditec is recalling 4,907 IOLMaster devices because an incorrect lens constant in the internal database could lead to the implantation of intraocular lenses with the wrong power.

    Product
    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primari
    Category
    Distribution
    0 states