MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-17 for SYNERGEYES HYBRID CONTACT LENS SA79M-0075 manufactured by Synergeyes.
[17276043]
On (b)(6) 2015, synergeyes received report of a complaint wherein the reason for return was stated as "laceration" further investigation determined that the reason for return was in fact "ulcer". On february 03, 2015, synergeyes received the corresponding lens and accompanying complaint report from the ecp. Paperwork indicated that "ulcer" was the reason for return, this was verified with ecp. The report also stated: on (b)(6) 2015, "patient noticed irritation in the left eye, took lens out, felt some relief, tried to wear lens again with lots of pain. " it was indicated that the patient had no pre-existing or recurring conditions that may have preceded the ulcer. Treatment was stated as being therapeutic with prescriptions of "vigamox sig: 1 drop os every 2 hours while awake and cycloplegic [dilation] drops [administered one time only ] in office. " on (b)(6) 2014, (b)(6) with my eye dr was contacted and the reason for return was confirmed as being ulcer, not laceration. On (b)(6) 2015, synergeyes contacted (b)(6) and the following information was obtained: re-affirmed that patient does not have any pre-existing or recurring conditions. Event occurred approximately 1 month after dispensation. Event resolved as of (b)(6) 2015. Patient is doing well with replacement lens.
Patient Sequence No: 1, Text Type: D, B5
[17452218]
During the investigation, the following information was obtained: based curve was measure by radius scope and power was measured by lensometer. Both bc and power were found to be within specifications. During surface inspection, the lens was able to wet properly and no known defects were detected. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2015-00002 |
| MDR Report Key | 4531614 |
| Report Source | 05 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-01-22 |
| Device Manufacturer Date | 2014-10-28 |
| Date Added to Maude | 2015-02-23 |
| 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 | 2015-02-17 |
| Returned To Mfg | 2015-02-03 |
| Model Number | SA79M-0075 |
| Lot Number | 061243 |
| Device Expiration Date | 2019-09-01 |
| 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 |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-17 |