MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-16 for SYNERGEYES HYBRID CONTACT LENS SP79S-0375+025030 manufactured by Synergeyes.
[17998292]
On (b)(6) 2014, synergeyes received a complaint wherein the patient (pt) sustained redness and irritation in left eye (os). Report state: "there is something on the lens irritating pt's eye. On (b)(6) 2014 synergeyes contacted dr (b)(6) and it is was asserted that the redness in the eye of the pt was an injury due to the fact that a medication was required to resolve the symptom; however, the alleged injury resolved in a "couple of days". The pt had received the replacement lenses and was trying them out. On (b)(6) 2014 synergeyes spoke with (b)(6), an office attendant for dr (b)(6) and the following information was obtained: (b)(6) 2014 was the date of the event. Redness occured in the os. Vigamox was the prescribed medication that resolved the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[18232043]
During the investigation the following information was obtained: base curve was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within manufacturing specifications. No defects were noted on surface and no correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00017 |
| MDR Report Key | 3961685 |
| Report Source | 05 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-07-14 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2014-05-28 |
| Date Added to Maude | 2014-07-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KINCADE, QA 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 HYBRID CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-06-16 |
| Returned To Mfg | 2014-06-30 |
| Model Number | SP79S-0375+025030 |
| Lot Number | 058220 |
| Device Expiration Date | 2019-04-01 |
| 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 |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-16 |