MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-27 for SYNERGEYES KC HYBRID DW LENS FOR KERATOCONUS CK60Z-0900 manufactured by Synergeyes, Inc..
[4110687]
On (b)(6) 2013, synergeyes received a complaint that a pt had a corneal abrasion. Discomfort and abrasion are typical warning signs to the practitioner that the contact lens may not have been properly fit, which can sometimes be difficult in keratoconic eyes. Abrasion and discomfort are not injuries as they generally resolve without treatment upon removal of the lens. In this case, the practitioner stated that antibiotic treatment was administered to address a corneal condition secondary to wearing of a synergeyes contact lens that was torn by the end-user, and we have been unable to obtain further info regarding the purpose of the treatment, nor rule out the lens as the cause, an mdr is being filed.
Patient Sequence No: 1, Text Type: D, B5
[11379377]
The lens was returned to synergeyes torn, specifically the rgp and soft skirt separated at the junction. Separations are attributed to pt use and handling. In this case, the pt had worn the lens approx 6 weeks prior to the event of a superficial corneal abrasion. The review of the associated device history record did not indicate any processing or qc issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2013-00013 |
| MDR Report Key | 3514498 |
| Report Source | 05 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-08-17 |
| Date Mfgr Received | 2013-10-11 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-12-13 |
| 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 KC HYBRID DW LENS FOR KERATOCONUS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2013-11-27 |
| Returned To Mfg | 2013-10-11 |
| Model Number | CK60Z-0900 |
| Lot Number | 050425 |
| Device Expiration Date | 2018-03-01 |
| 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 | 2013-11-27 |