MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for OPMI VARIO manufactured by Carl Zeiss.
[100644131]
Patient Sequence No: 1, Text Type: N, H10
[100644132]
The bulb in the or microscope burned out. The back-up bulb was dim and sub-optimal for delicate eye cases. The eye was already open and cataract/lens removed, so it could not be cancelled/re-scheduled. The backup bulb is identical to the primary bulb and should function with the same intensity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7285400 |
| MDR Report Key | 7285400 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-01-23 |
| Report Date | 2018-02-07 |
| Date Reported to FDA | 2018-02-07 |
| Date Reported to Mfgr | 2018-02-07 |
| Date Added to Maude | 2018-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI VARIO |
| Generic Name | MICROSCOPE, SURGICAL |
| Product Code | FSO |
| Date Received | 2018-02-21 |
| Model Number | OPMI VARIO |
| ID Number | SERIAL NUMBER 6629503473 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS |
| Manufacturer Address | ONE ZEISS DR THORNWOOD NY 10594 US 10594 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |