MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-14 for SYNERGEYES HYBRID DAILY CONTACT LENS KS6582-0850 NA manufactured by Synergeyes, Inc..
[19592392]
On (b)(6) 2014, synergeyes received a customer complaint form stating that a pt with keratoconus had suffered a superior epithelial arcuate lesion on the pt's os. On (b)(6) 2014, the pt was seen at the (b)(6) for a f/u. (b)(6) stated that the os appeared to be "bloodshot" with a relative severity of "8/10. " the synergeyes lens was removed and (b)(6) observed a chip on the edge of the lens and subsequently made the diagnosis that the superior epithelial arcuate lesion on the pts os was caused by the damaged lens. On (b)(6) 2014, synergeyes contacted the (b)(6) to obtain add'l info. Customer stated the pt's keratoconus condition combined with the chipped lens was the cause of the epithelial lesion on the pt's os. Moreover, customer stated that damage to lens was likely due to pt handling. (b)(6) stated that symptoms included severe redness and irritation on the pts os which lasted 3-4 days. Pt was given tobradex qid for 5 days and condition resolved by next f/u with slight scar.
Patient Sequence No: 1, Text Type: D, B5
[19916995]
During the investigation, the following info was obtained: lens surface was inspected using an optical microscope. The lens sustained a chip on the edge of the lens skirt. Base curve was measured using a radioscope. The lens' measured parameter was within the lens design spec. Power was measured using a lensometer. The lens' measured power was within the lens design spec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00007 |
| MDR Report Key | 3703840 |
| Report Source | 05 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-03-13 |
| Date of Event | 2014-01-20 |
| Date Mfgr Received | 2014-02-26 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-03-28 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES HYBRID DAILY CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-03-14 |
| Returned To Mfg | 2014-02-26 |
| Model Number | KS6582-0850 |
| Catalog Number | NA |
| Lot Number | 054866 |
| Device Expiration Date | 2018-11-01 |
| 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 | CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-14 |