MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-28 for SYNERGEYES HYBRID DAILY WEAR CONTACT LENS MP7184-0475+017522 NA manufactured by Synergeyes, Inc..
[20006794]
On (b)(6) 2014 synergeyes received a report wherein a patient had evidence of corneal edema in the patient's left eye. The report stated that the patient started wearing the contact lens involved in the event "around" (b)(6) 2014. The patient was seen by the physician on (b)(6) 2014 for pain in her left eye. Results of the examination determined that the patient's left lens was fitting snug on the cornea causing corneal edema. Treatment of the corneal edema was limited to the patient receiving tobradex. Based on the physician's statement, tobradex should resolve the corneal edema with no long term issues expected. It was reported that the physician did not know if the lens caused or contributed to the event as the patient's rx has not changed and the patient's last set of lenses were worn with no issue.
Patient Sequence No: 1, Text Type: D, B5
[20182458]
During the complaint investigation the following information was obtained: lens surface was inspected using an optical microscope. There were no surface defects noted. Base curve was measured using a radioscope. The lens' measured parameter was within the lens design specification. Power was measured using a lensometer. The lens' measured parameter was within the lens design specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00004 |
| MDR Report Key | 3609039 |
| Report Source | 05 |
| Date Received | 2014-01-28 |
| Date of Report | 2014-01-28 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-16 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-02-06 |
| 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, 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 HYBRID DAILY WEAR CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-01-28 |
| Returned To Mfg | 2014-01-16 |
| Model Number | MP7184-0475+017522 |
| Catalog Number | NA |
| Lot Number | 051171 |
| Device Expiration Date | 2018-05-01 |
| 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 | 2232 RUTHERFORD ROAD CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-28 |