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 2020-03-02 for VISULAS GREEN N/A 000000-2096-102 manufactured by Carl Zeiss Meditec Ag (jena).
| Report Number | 9615030-2020-00005 |
| MDR Report Key | 9777391 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-02 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-02 |
| Device Manufacturer Date | 2019-01-31 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 5574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA 7745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 7745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISULAS GREEN |
| Generic Name | LASER, OPHTHALMIC |
| Product Code | HQF |
| Date Received | 2020-03-02 |
| Model Number | N/A |
| Catalog Number | 000000-2096-102 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA 7745 GM 7745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |