MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-13 for SYNERGEYES HYBRID DAILY CONTACT LENS CK15M-0400 NA manufactured by Synergeyes, Inc..
[16800734]
On (b)(6) 2014, synergeyes received a customer complaint form stating that the patient suffered a corneal abrasion. The patient notified the doctor that the synergeyes contact lens had a chip on the edge. After noticing the chip, the patient removed the lens, replacing the lens with a previously worn contact lens. This action led to the subsequent abrasion/corneal ulcer on the patient's os. On (b)(6) 2014 synergeyes contacted family eye clinic to obtain additional information and was informed that the chip on the synergeyes lens did not cause the abrasion/corneal ulcer. Customer stated that the abrasion/corneal ulcer was a result of the patient inserting the previously worn lens. The patient was treated with zymaxid and oxyfloaacin on (b)(6) 2014. On (b)(6) 2014 the patient returned to family eye clinic. The physician stated that the patient showed signs of improvement with the condition resolving with treatment. The synergeyes lens was replaced with a new lens and is wearing the lens with no further issues.
Patient Sequence No: 1, Text Type: D, B5
[17050765]
During the investigation the following information was obtained: lens surface was inspected using an optical microscope. The lens sustained a chip and tear in the lens skirt. Base curve was measured using a radioscope. The lens' measured parameter was within the lens design specification. Power was measured using a lensometer. The lens' measured power was within the lens design specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00006 |
| MDR Report Key | 3750713 |
| Report Source | 05 |
| Date Received | 2014-03-13 |
| Date of Report | 2014-03-12 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-02-26 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-04-16 |
| 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 | 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 | 2014-03-13 |
| Returned To Mfg | 2014-02-26 |
| Model Number | CK15M-0400 |
| Catalog Number | NA |
| Lot Number | 053459 |
| ID Number | NA |
| Device Expiration Date | 2018-09-01 |
| 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 | 2014-03-13 |