MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-01 for SYNERGEYES HYBRID CONTACT LENS SM73F-0625+STDSM manufactured by Synergeyes.
[6059439]
On (b)(6) 2015, synergeyes received a complaint wherein the ecp indicated that a superficial defect in the superior cornea had occurred, the defect was also indicated as an ulcer. The ecp indicated that the event was not sight threatening, however vigamox was "therapeutically" applied four times daily for 10 days while the patient was instructed to discontinue lens wear. The event had resolved on (b)(6) 2015. At time of contact with the ecp, the patient had returned to using an older lens with some lens awareness, while the replacement lens had not been dispensed.
Patient Sequence No: 1, Text Type: D, B5
[14146615]
Although no device was returned, synergeyes conducted a process review and no correlation was found between the device history record and the alleged event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2015-00005 |
| MDR Report Key | 4886356 |
| Report Source | 05 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-05-21 |
| Date Mfgr Received | 2015-06-09 |
| Device Manufacturer Date | 2015-04-23 |
| Date Added to Maude | 2015-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KINCADE |
| 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 HYBRID CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2015-07-01 |
| Model Number | SM73F-0625+STDSM |
| Lot Number | 064496 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-01 |