MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-06 for SYNERGEYES HYBRID CONTACT LENS CK10S+0650 manufactured by Synergeyes.
[17934662]
On (b)(6) 2015, synergeyes received a complaint wherein the reasons for return were "corneal ulcer" and "defective". Report stated, "two lenses stuck together" and attempted to describe how this occurred, "patient had lens in eye for two weeks and unaware - took lens out. " also included was that the patient noticed a bump under upper lid due to irritation for two days. Treatment indicated was therapeutic vigamox, which had resolved the issue with no secondary complications by the date of the report. On (b)(6) 2015, synergeyes contacted ecp and the following information was obtained: ecp confirmed ulcer occurred. Stated that patient wore two lenses in the affected eye at the same time. This is not a recommended procedure. Also stated patient was unaware first lens had been in eye upon insertion of second lens. Lenses torn upon removal.
Patient Sequence No: 1, Text Type: D, B5
[18196041]
Our review of the device history record of the reported lens did not indicate any issues that would have contributed to an injury of this nature without the patient using two synergeyes lenses in one eye, which is not a recommended procedure. Although lenses were returned, they were not accompanied by any paperwork. The relevant paperwork was returned at a later date and by the time the paperwork arrived, the lenses had been discarded by the returns department. There was no indication on any received packaging that the lenses were related to any injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2015-00003 |
| MDR Report Key | 4663455 |
| Report Source | 05 |
| Date Received | 2015-04-06 |
| Date of Report | 2014-04-01 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-03-13 |
| Device Manufacturer Date | 2014-11-19 |
| Date Added to Maude | 2015-04-08 |
| 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 | 2015-04-06 |
| Model Number | CK10S+0650 |
| Lot Number | 061674 |
| Device Expiration Date | 2019-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-04-06 |