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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to the implantation of a lens with the wrong diopter value, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Carl Zeiss Meditec, Inc. is recalling 1,201 units of the Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp. The devices were distributed nationwide. The recall is due to an erroneous value in the internal lens database used for download.
Specifically, the "aO" constant for the AMO Sensar AR40E lens is listed as "0.0" in the device's database, whereas the correct value is -2.420. This error could lead to the implantation of a lens with an incorrect diopter value. The device is intended for use primarily by physicians and health care workers under the supervision of a physician to determine ocular measurements and assist in selecting intraocular lens power and type.
Health care providers should check the serial number of their IOLMaster 500 device against the list of affected units provided by the manufacturer. If the device is affected, it should be removed from service and returned to Carl Zeiss Meditec, Inc. for repair or replacement.
The recalled product
- 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
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Affected units
- 1,201
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Carl Zeiss Meditec, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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