MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-26 for SYNERGEYES HD HYBRID CONTACT LENSES SEE H10 NA manufactured by Synergeyes, Inc..
[4049979]
On (b)(6) 2013, synergeyes received a complaint wherein the practitioner stated that the patient's poorly fit lens caused a corneal erosion which led to a corneal abrasion the patient was treated with besivance tid and lotemax qid. The patient stopped wearing the lenses and the signs and symptoms of the corneal abrasion rapidly resolved. Synergeyes suggested that the practitioner refit the lenses.
Patient Sequence No: 1, Text Type: D, B5
[11495975]
There were two lenses involved in the event: right eye (od) and left eye (os). Od lens - model number: mp7787-0225+017519, lot number: 048792, expiration date: 12/01/2017, date manufactured: 01/01/2013. Os lens - model number: mp7787-0200+017522, lot number: 048573, expiration date: 12/01/2017, date manufactured: 01/01/2013. The lenses were 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 on the front or base curve surfaces.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2013-00016 |
| MDR Report Key | 3553312 |
| Report Source | 05 |
| Date Received | 2013-12-26 |
| Date of Report | 2013-12-26 |
| Date of Event | 2013-09-20 |
| Date Mfgr Received | 2013-12-03 |
| Date Added to Maude | 2014-01-07 |
| 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, DIRECTOR |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604449636 |
| Manufacturer G1 | SYNERGEYES, INC. |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES HD HYBRID CONTACT LENSES |
| Generic Name | CONTACT LENSES |
| Product Code | HQD |
| Date Received | 2013-12-26 |
| Returned To Mfg | 2013-12-03 |
| Model Number | SEE H10 |
| Catalog Number | NA |
| Lot Number | SEE H 10 |
| ID Number | NA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-26 |