# K122418: Iolmaster 500

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Apr 12, 2013 after 247 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K955442 (1996). 20 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101182: Iolmaster 500, Carl Zeiss Meditec, AG (2010) Summary page 2.

## Most influential descendants
- K143275: IOLMaster700 (2015), 4 descendants of its own
- K170171: IOLMaster 700 (2017), 3 descendants of its own
- K152311: Pentacam AXL (2016), 3 descendants of its own
- K173771: IOLMaster 700 (2018), 1 descendant of its own
- K252633: Unity DX (Udx) (2025), 0 descendants of its own

## Recalls of this device
- Oct 27, 2015 · Class II · Z-0357-2016: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
- Oct 27, 2015 · Class II · Z-0358-2016: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
- Oct 23, 2013 · Class II · Z-0333-2014: 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. Th
- Oct 23, 2013 · Class II · Z-0334-2014: 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. Th

## Indications for use
The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation. This device is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.

Source page: https://510kreport.com/device/K122418
Methodology: https://510kreport.com/methodology