MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-09 for SYNERGEYES DUETTE MULTIFOCAL SM75 SM manufactured by Synergeyes, Inc..
[39012581]
No contact lens was returned for evaluation. Physician did not provide additional information regarding patient condition of treatment as of date of this report.
Patient Sequence No: 1, Text Type: N, H10
[39012582]
Physician reported on (b)(6) 2015 that patient experienced severe superficial punctate keratitis (spk) after wearing contact lens for 9-12 hours per day for one to three weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005087645-2016-00001 |
| MDR Report Key | 5459792 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-09 |
| Date of Report | 2016-01-27 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2015-12-28 |
| Date Added to Maude | 2016-02-25 |
| 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 | KAREN KINCADE |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 8777332012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES DUETTE MULTIFOCAL |
| Product Code | HQD |
| Date Received | 2016-02-09 |
| Model Number | SM75 |
| Catalog Number | SM |
| Lot Number | 068545 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| 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 | 2016-02-09 |