MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) CALLISTO EYE

Catalog Number	301640-3020-350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Before starting a surgery with callisto eye, the position of the health care professional (hcp) must be set in relation to the patient's head (right, left, or top).The selected position is indicated on the live video screen throughout the surgery.In this particular case, the "right" position was selected in callisto eye, but the hcp was physically positioned near the top of the patient's head.This caused the 90 degree discrepancy in the displayed target axis.
Event or Problem Description
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.

• Brand Name: CALLISTO EYE
• Common Device Name: CALLISTO EYE
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• MDR Report Key: 7023374
• Report Number: 9615010-2017-00012
• Device Sequence Number: 1006157
• Product Code: NFJ
• UDI-Device Identifier: 04049539103512
• UDI-Public: 4049539103512
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 301640-3020-350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other