MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-20 for EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR EMERALD manufactured by Euclid Systems Corporation.
| Report Number | 3002652243-2019-00002 |
| MDR Report Key | 9099317 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-08-22 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2019-09-20 |
| 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 | MS. SANDRA GILBERT |
| Manufacturer Street | 45472 HOLIDAY DRIVE SUITE 7 |
| Manufacturer City | STERLING VA 20166 |
| Manufacturer Country | US |
| Manufacturer Postal | 20166 |
| Manufacturer Phone | 7034717145 |
| Manufacturer G1 | EUCLID SYSTEMS CORPORATION |
| Manufacturer Street | 2776 TOWERVIEW RD |
| Manufacturer City | HERNDON VA 20171 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20171 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR |
| Generic Name | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR |
| Product Code | NUU |
| Date Received | 2019-09-20 |
| Returned To Mfg | 2019-08-26 |
| Model Number | EMERALD |
| Lot Number | 18158PTC006 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EUCLID SYSTEMS CORPORATION |
| Manufacturer Address | 2776 TOWERVIEW RD HERNDON VA 20171 US 20171 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-20 |