MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-10 for EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR SAPPHIRE manufactured by Euclid Systems Corporation.
[189074063]
The subject device was not returned for investigation. No anomalies or discrepancies observed upon review of the device history record(s). Per doctor, the patient was treated with oral antibiotic and drops to help the infection. There was no report of any laceration or abrasion. Patient discontinued lens wear for two weeks. Doctor requested replacement lenses for the patient on (b)(6) 2020.
Patient Sequence No: 1, Text Type: N, H10
[189074064]
On (b)(6) 2020, euclid systems corporation was notified of a patient experiencing an eye infection. Patient was treated with oral antibiotics and drops to treat the infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002652243-2020-00001 |
| MDR Report Key | 9577577 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2019-04-09 |
| Date Added to Maude | 2020-01-10 |
| 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 | 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 | 2020-01-10 |
| Model Number | SAPPHIRE |
| Lot Number | 18257PTC003 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-10 |