IOLMaster 500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049471092066), received between Apr 15, 2022 and Apr 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K122418, K141068); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE AXIAL LENGTH USED FOR IOL CALCULATION WAS NOT THE AXIAL LENGTH THAT WAS MEASURED BY THE IOLMASTER 500. THE ISSUE WAS NOT CAUGHT PRIOR TO SURGERY AND A REFRACTIVE SURPRISE ON THE PATIENT'S RIGHT EYE OCCURRED. THE DOCTOR REPORTED THAT HE HAD IMPLANTED THE WRONG LENS INTO THE PATIENT'S EYE. THE PATIENT IS NOW NEAR SIDED. THE DOCTOR REPORTED THAT HE IS PLANNING TO EXPLANT THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 14118811 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122418, K141068. One submission often covers many models, so check the product and lot details in each record.

• Z-0358-2016 · Oct 27, 2015 · Terminated
  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, c
• Z-0357-2016 · Oct 27, 2015 · Terminated
  IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and t
• Z-0333-2014 · Oct 23, 2013 · Terminated
  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; a
• Z-0334-2014 · Oct 23, 2013 · Terminated
  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;