MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for DUETTE LENS manufactured by Synergyeyes.
[83620356]
Pt using different brand of contact lens in each eye. In left eye, used synergyeyes duette lens and developed acanthamoeba keratitis, a very serious infection. Date of use: (b)(6) 2016. Diagnosis or reason for use: refractive error/ myopia. "event abated after use stopped or dose reduced: yes, is the product compounded: no, is the product over-the-counter: no. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071768 |
| MDR Report Key | 6816511 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-14 |
| Date of Event | 2016-10-10 |
| Date Added to Maude | 2017-08-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | DUETTE LENS |
| Generic Name | LENS, CONTACT (OTHER MATERIAL) DAILY |
| Product Code | HQD |
| Date Received | 2017-08-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGYEYES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-24 |