MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for SPHERE manufactured by Metro Optics Of Austin, Inc. Austin, Tx.
| Report Number | 1627258-2018-00001 |
| MDR Report Key | 9125330 |
| Date Received | 2019-09-26 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-03-26 |
| Date Added to Maude | 2019-09-26 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPHERE |
| Generic Name | BOSTON XO STANDAD SPHERE LENS |
| Product Code | HQD |
| Date Received | 2019-09-26 |
| Returned To Mfg | 2018-03-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METRO OPTICS OF AUSTIN, INC. AUSTIN, TX |
| Manufacturer Address | P.O. BOX 81189 AUSTIN TX 78708 US 78708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-26 |