MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-30 for SYNERGEYES HYBRID CONTACT LENS AS7686+0325 manufactured by Synergeyes, Inc..
[5500865]
On january 14, 2015, synergeyes received a complaint wherein the reason for return was ulcer. The report state: "patient noticed discomfort" on the date (b)(6) 2014. It was indicated that the pt had no pre-existing or recurring conditions that may have preceded the ulcer. Treatment was administered by a different practice while the pt was away for college. Between (b)(6) 2015, four calls were made to (b)(6) from the (b)(6). On (b)(6) 2015, synergeyes contacted (b)(6) and the following information was obtained: conditions has resolved with no secondary complications. Pt is doing well with replacement lenses dispensed on (b)(6) 2014. There was a follow-up appointment with the pt on (b)(6) 2014 with no indication of condition recurrence. Zymaxid ab topical drops were prescribed by another ecp, pt mentioned an oral pill had been taken, but (b)(6) did not at the time know which pill. (b)(6) would try to contact pt to see if pt was willing to sign a release of information form. On (b)(6), (b)(6) was contacted again and she stated that the pt had been willing to sign the release and was waiting for the records to be sent. On (b)(6), (b)(6) was contacted a final time and had the records. The following information was obtained: (b)(6) is the clinic the pt visited near the college. The oral pill prescribed was benadryl. The condition was not pre-existing, no information on file regarding whether ecp through ulcer was due to the lens.
Patient Sequence No: 1, Text Type: D, B5
[12798991]
During the investigation the following information was obtained: base curve was measured by radius scope and power was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within specifications. During surface inspection, the lens was able to wet properly after cleaning and although a known stippling effect was found on the soft skirt fo the lens, it passed the manufacturing specifications and is unlikely to have contributed to the alleged injury. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2015-00001 |
| MDR Report Key | 4473184 |
| Report Source | 05 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-28 |
| Date of Event | 2014-11-06 |
| Date Mfgr Received | 2015-01-14 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-02-03 |
| 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 LESN |
| Product Code | HQD |
| Date Received | 2015-01-30 |
| Returned To Mfg | 2015-01-14 |
| Model Number | AS7686+0325 |
| Lot Number | 059228 |
| Device Expiration Date | 2019-06-01 |
| 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 | 2015-01-30 |