# K993357: Iolmaster

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Mar 20, 2000 after 166 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: 1 generation back to K781994 (1979). 4 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961171: Humphrey Oct Scanner, Carl Zeiss, Inc. (1996) Summary page 1.
- K925641: Zeiss 20 SL Slit-Lamp & Mechanical Micromanipulatr, Carl Zeiss, Inc. (1993) Summary page 1.
- K926251: B-Scan Opthalmic Ultrasound Imaging System, Biovision, Inc. (1993) Summary page 1.
- K781994: Autokeratometer, Instrument, Zeiss Humphrey System (1979) Summary page 1.

## Most influential descendants
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter (2003), 16 descendants of its own
- K082891: Lenstar, Model LS900 (2009), 14 descendants of its own
- K101182: Iolmaster 500 (2010), 10 descendants of its own
- K122418: Iolmaster 500 (2013), 9 descendants of its own
- K143275: IOLMaster700 (2015), 4 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
This device will be used in the same manner as all ophthalmic diagnostic devices used to obtain ocular measurements (for axial length, anterior chamber depth and corneal radius), and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

Source page: https://510kreport.com/device/K993357
Methodology: https://510kreport.com/methodology