MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-12 for SYNERGEYES SILICONE HYBRID CONTACT LENSES SM73F-0475+STDSM NA manufactured by Synergeyes, Inc..
[4002615]
On (b)(6) 2013, the od contacted synergeyes to report that a pt developed pannis over time with the use of the contact lens. Pt was instructed to discontinue the use of the lens. Pt status is good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005087645-2013-00008 |
| MDR Report Key | 3491012 |
| Report Source | 05 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-10-15 |
| Date Mfgr Received | 2013-10-25 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-11-29 |
| 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, DIRECTOR |
| 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 SILICONE HYBRID CONTACT LENSES |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2013-11-12 |
| Model Number | SM73F-0475+STDSM |
| Catalog Number | NA |
| Lot Number | 050103 |
| ID Number | NA |
| Device Expiration Date | 2018-03-01 |
| 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, INC. |
| Manufacturer Address | CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-12 |