MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-29 for SYNERGEYES HYBRID CONTACT LENS SA73F-0700 manufactured by Synergeyes.
[20785975]
On (b)(6) 2014, synergeyes received a complaint where in the reason for the return was redness, irritation, and infection. Report stated: "left eye (os) became red and painful. Was treated for eye infection (not seen at our office). Lens sat tight on conjunctiva. " on (b)(4) 2014, synergeyes contacted "(b)(6)" an office attendant for dr. (b)(6). The following information was obtained: patient (pt) did not have any pre-existing conditions. Unclear on whether or not infection was caused by contact lens (cl) since pt saw their physical care physician (pcp) before seeing eye care physician (ecp) and had stopped wearing lenses. On (b)(6) 2014, after further attempts to contact, dr. (b)(6) called back. The following information was obtained. Pt's pcp had prescribed an anti-biotic for pt's os, dr. (b)(6) does not know the name of the prescribed medication. Also unknown whether infection was actually present or if the antibiotic was a precaution.
Patient Sequence No: 1, Text Type: D, B5
[20945366]
During the investigation the following information was obtained: base curve was measured by radioscope and power was measured by lensometer. Both bc and power were found to be within specifications. Although deposits were found they were removed by swab and saline. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00021 |
| MDR Report Key | 4072036 |
| Report Source | 05 |
| Date Received | 2014-08-29 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-06-10 |
| Date Mfgr Received | 2014-08-04 |
| Device Manufacturer Date | 2014-02-05 |
| Date Added to Maude | 2014-09-10 |
| 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 LENS |
| Product Code | HQD |
| Date Received | 2014-08-29 |
| Returned To Mfg | 2014-08-04 |
| Model Number | SA73F-0700 |
| Lot Number | 055956 |
| Device Expiration Date | 2019-01-01 |
| 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 | 2014-08-29 |