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CALLISTO eye Panel PC Model IIRecalls & reported problems

Carl Zeiss Meditec AG · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049539103512), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A TORIC IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE 90 DEGREES OFF THE DESIRED AXIS. THE MARKERLESS FUNCTION OF THE CALLISTO EYE HAD BEEN USED TO POSITION THE IOL. THE PATIENT'S ASTIGMATIC OUTCOME WAS ABOUT 6.0 DIOPTERS, WHICH RESULTED IN POOR VISUAL ACUITY. THE HCP DECIDED TO PERFORM A FOLLOW-UP SURGERY USING THE CALLISTO EYE TO RE-POSITION THE IOL. AFTER THE CORRECTIVE TREATMENT, THE PATIENT'S ASTIGMATISM IS ABOUT 0.25 DIOPTERS.

    Patient problems: No Code Available

    MAUDE report 7023374 ↗

Other System, Digital Image Communications, Radiological devices

All System, Digital Image Communications, Radiological devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.