MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for WAVE CONTACT LENS manufactured by Metro Optics Of Austin, Inc.
| Report Number | 1627258-2018-00002 |
| MDR Report Key | 9125332 |
| Date Received | 2019-09-26 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2018-05-07 |
| 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 |
| Manufacturer Contact | MR. STEVE WEBB |
| Manufacturer Street | P.O. BOX 81189 |
| Manufacturer City | AUSTIN TX 78708 |
| Manufacturer Country | US |
| Manufacturer Postal | 78708 |
| Manufacturer Phone | 5122512382 |
| Manufacturer G1 | METRO OPTICS OF AUSTIN, INC |
| Manufacturer Street | P.O. BOX 81189 |
| Manufacturer City | AUSTIN TX 78708 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78708 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WAVE CONTACT LENS |
| Generic Name | WAVE ORTHO-K LENS IN BOSTON XO2 |
| Product Code | HQD |
| Date Received | 2019-09-26 |
| Returned To Mfg | 2018-07-20 |
| 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 |
| Manufacturer Address | P.O. BOX 81189 AUSTIN TX 78708 US 78708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-26 |