MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-18 for SYNERGEYES HYBRID CONTACT LENS KS6582-1200 manufactured by Synergeyes, Inc..
[4605749]
On (b)(4) 2014, synergeyes received a complaint wherein the pt (pt) sustained corneal erosion. Report stated: "infiltrate or nodule at the junction site of contact lens (cl)". The alleged injury resolved with a prescription of zylet. The pt has a pre-existing condition of keratoconus, and though there was allegedly irritation pt continued to wear the lens. "unaware the lens could be defective". On (b)(4) 2014, synergeyes attempted a good faith effort to obtain further info from laura hardy, an office attendant for eyesight ophthalmic services, by phone and a message was left on voicemail. On (b)(4) 2014, synergeyes attempted to contact laura hardy again, unsuccessfully.
Patient Sequence No: 1, Text Type: D, B5
[12099052]
During the investigation the following info was obtained: base curve was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within specifications. Although an irremovable deposit and minor scratches were found on the surface of the lens, this is most likely due to long-term pt use. Upon return, it was determined that the lens had been worn two months beyond the recommended life expectancy of 6 months and was beyond the warranty date. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00018 |
| MDR Report Key | 3954587 |
| Report Source | 05 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-06-19 |
| Date Mfgr Received | 2014-06-27 |
| Device Manufacturer Date | 2013-10-17 |
| Date Added to Maude | 2014-07-25 |
| 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, 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 | 2014-07-18 |
| Model Number | KS6582-1200 |
| Lot Number | 053734 |
| Device Expiration Date | 2018-09-01 |
| Operator | LAY USER/PATIENT |
| 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 | 2014-07-18 |