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.
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 is classified as FDA Class II. The hazard involves a risk of harm (incorrect IOL power) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Carl Zeiss Meditec, Inc. is recalling 4,907 units of the Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered. The device is intended for use primarily by physicians and health care workers under the supervision of a physician for biometric determination of ocular measurements and to assist in determining the appropriate intraocular lens (IOL) power and type for implantation.
The recall is due to an erroneous value in the user database delivered for download. Specifically, the "aO" constant for the AMO Sensar AR40E lens is listed as "0.0" in the internal lens database of the IOLMaster, whereas the correct value is -2.420. This error could lead to the implantation of a lens with a wrong diopter value.
The affected devices were distributed nationwide. Healthcare providers should check their serial numbers against the list provided by the manufacturer and contact Carl Zeiss Meditec, Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Affected units
- 4,907
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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