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 2020-03-30 for STELLARIS ELITE VISION ENHANCEMENT SYSTEM BL2351 manufactured by Bausch + Lomb.
[185799416]
The device history was reviewed and found to meet manufacturing specifications. Additional information has been requested. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[185799417]
A user facility in portugal reported that during their last surgery session, the system turned off by itself a couple of times. Both times the system was turned back on and continued to work without any problems. All scheduled surgeries were completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00055 |
| MDR Report Key | 9900269 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | MRS. JULI MOORE |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLARIS ELITE VISION ENHANCEMENT SYSTEM |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-30 |
| Model Number | BL2351 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-30 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |