MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-10 for CALLISTO EYE 301640-3020-350 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[91801534]
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.
Patient Sequence No: 1, Text Type: N, H10
[91801535]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00012 |
| MDR Report Key | 7023374 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-10 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2014-08-14 |
| Date Added to Maude | 2017-11-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALLISTO EYE |
| Generic Name | CALLISTO EYE |
| Product Code | NFJ |
| Date Received | 2017-11-10 |
| Model Number | NA |
| Catalog Number | 301640-3020-350 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-10 |