MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-07 for SYNERGEYES KS6982-0700 NA manufactured by Synergeyes, Inc..
[4026974]
On (b)(6) 2013 synergeyes was notified of a pt injury. As reported, on (b)(6) 2013, the pt inserted the synergeyes lens which caused irritation to the pt's eye. The pt went to the od for treatment wherein the od determined that the pt scratched her cornea causing an infection. The pt's infection was treated and the pt recovered well. It is not known what medical intervention was utilized to treat the pt. The pt is now wearing a new set of synergyeyes lenses with no further complications.
Patient Sequence No: 1, Text Type: D, B5
[11413341]
The lens was measured for base curve and power, the results demonstrated that the lens met the labeled parameters. Results of the surface inspection determined that there were no defects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2013-00009 |
| MDR Report Key | 3476787 |
| Report Source | 05 |
| Date Received | 2013-11-07 |
| Date of Report | 2013-11-07 |
| Date of Event | 2013-10-03 |
| Date Mfgr Received | 2013-10-16 |
| Device Manufacturer Date | 2013-03-07 |
| Date Added to Maude | 2013-11-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KINCADE, DIR |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604449636 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2013-11-07 |
| Returned To Mfg | 2013-10-16 |
| Model Number | KS6982-0700 |
| Catalog Number | NA |
| Lot Number | 049509 |
| ID Number | NA |
| Device Expiration Date | 2018-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES, INC. |
| Manufacturer Address | CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-07 |