MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-27 for SYNERGEYES HYBRID CONTACT LENS KC6179-1550 manufactured by Synergeyes.
[5067792]
On (b)(6) 2014, synergeyes received a complaint wherein the reason for return was abrasion. Report stated that the patient (pt) was allegedly injured while wearing the lens, that the alleged injury did not heal on its own having required a prescription of, "zylet bid. " pt had pre-existing condition of keratoconus, the report also stated that the pt had contributed to the alleged injury by not observing that the contact lenses had torn or chipped skirts and still using them. From (b)(6) 2014, five attempts to contact the ecp were made. On (b)(6) 2014 synergeyes received the following information from (b)(6): abrasion was in both eyes (ou). Confirmed that pt has keratoconus. (b)(6) stated that the ecp believes that the abrasion penetrated the corneal epithelium. Use of prescription medication zylet was considered by the doctor to be therapeutic. Pt still has "slight corneal scarring, though it is healing. " pt had been in that morning and (b)(6) stated that the ecp's diagnosis was that the patient had "keratoconus and epiphora. "
Patient Sequence No: 1, Text Type: D, B5
[12533859]
During the investigation the following information was obtained: a second lens was returned as part of the same complaint. Its specifications were determined to be as follows: lot number: 058465, part number: ks6179-1550, expiration date: 05/01/2019. The base curve (bc) was measured by radius scope and power was measured by lensometer for both lenses. For both lenses, the bc and power were found to be within specifications. Although the skirts of both lenses were torn, such an occurrence is consistent with regular patient use. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00025 |
| MDR Report Key | 4223261 |
| Report Source | 05 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-27 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2014-09-24 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-11-05 |
| 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 RD. |
| 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 | 2014-10-27 |
| Returned To Mfg | 2014-09-24 |
| Model Number | KC6179-1550 |
| Lot Number | 058751 |
| Device Expiration Date | 2019-05-01 |
| 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 | 2014-10-27 |