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 SA81Y+0200 manufactured by Synergeyes.
[5070181]
On (b)(6) 2014, synergeyes received a complaint wherein the reason for return was a corneal ulcer. Report stated that the ulcer did not heal on its own, the prescription was listed as, "antibiotic, ciloxan qid, condition improved. " the report also stated that the patient has the pre-existing or recurring condition of dry-eye syndrome. From (b)(6) 2014, five attempts were made to contact the ecp to attain more information. On (b)(6) 2014, (b)(6), was reached and the following information was obtained: ulcer was allegedly in the right eye (od). Pt has recurring condition dry eye syndrome and no others have been identified in this patient. (b)(6) stated that dr. (b)(6) had informed her that the use of ciloxan was therapeutic. As of (b)(6) 2014, the pt was doing well and using the new lens received from synergeyes with moderation and had reported that the lens was "clear and comfortable. "
Patient Sequence No: 1, Text Type: D, B5
[12605392]
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: 058175, part number: sa81y+0350, expiration date: 04/01/2019. 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 irremovable deposits were found on the surface of both lenses, this kind of incident can occur during regular pt use. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00026 |
| MDR Report Key | 4223260 |
| Report Source | 05 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-27 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2014-09-24 |
| Device Manufacturer Date | 2013-11-01 |
| 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 |
| 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 | 2014-09-26 |
| Model Number | SA81Y+0200 |
| Lot Number | 054234 |
| Device Expiration Date | 2018-10-01 |
| 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 |