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 2018-06-07 for OPMI LUMERA I N/A 305946-9900-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[110455807]
A healthcare professional (hcp) reported that that during the preparation of a cataract surgery, a screw from the objective lens of the opmi lumera i microscope came loose and fell into the patient's eye. The screw was removed from the patient's eye by the scrub nurse. The hcp was able to complete the surgery successfully using the same microscope. There was no injury to the patient due to the reported incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00007 |
| MDR Report Key | 7580744 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-07 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2015-06-23 |
| Date Added to Maude | 2018-06-07 |
| 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 | OPMI LUMERA I |
| Generic Name | MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2018-06-07 |
| Model Number | N/A |
| Catalog Number | 305946-9900-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-06-07 |