MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-28 for OPMI LUMERA I N/A 305946-9900-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[181479913]
The hcp communicated that when the surgeon maneuvered the device during the case, the plug connected to the stand was dislodged enough to lose power.
Patient Sequence No: 1, Text Type: N, H10
[181479914]
A healthcare professional (hcp) reported that during a case the power cord disconnected from the device. The device's power and light went out, which caused the doctor to rupture the patient's posterior eye capsule. The doctor had to do an anterior vitrectomy while the patient was under local monitored anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2020-00003 |
| MDR Report Key | 9771886 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2011-02-18 |
| Date Added to Maude | 2020-02-28 |
| 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. VERNON BROWN |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5574616 |
| 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 | OPMI LUMERA I |
| Generic Name | MICROSCOPE, OPHTHALMIC, OPERATING |
| Product Code | HRM |
| Date Received | 2020-02-28 |
| Model Number | N/A |
| Catalog Number | 305946-9900-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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. Required No Informationntervention | 2020-02-28 |