IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
Reported: December 9, 2015 Initiated: October 27, 2015 #Z-0358-2016
Product Description
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
Reason for Recall
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Details
- Recalling Firm
- Carl Zeiss Meditec AG
- Units Affected
- 1882
- Distribution
- Nationwide Distribution.
- Location
- Jena
Frequently Asked Questions
What product was recalled? ▼
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.. Recalled by Carl Zeiss Meditec AG. Units affected: 1882.
Why was this product recalled? ▼
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2015. Severity: Moderate. Recall number: Z-0358-2016.
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