MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-06 for SYNERGEYES HYBRID CONTACT LENS - AS AS7585-0750 manufactured by Synergeyes.
[15124825]
On (b)(6) 2014, synerg eyes received a complaint wherein the patient sustained corneal erosion in od. Report stated: the patient ordered new sets of lenses in early (b)(6) and saw the ecp on (b)(6) 2014, complaining that the od contact lens hurt after 1 to 2 hours of wear. Ecp stated there were no fit changes from the previous year and that, when examined, pt showed epithelial staining in an arc pattern. Eye-care professional (ecp) advised patient to stop wearing the lens and prescribed anti-tear. Pt was to return to ecp practice in 4 days for follow-up. Patient did not return for follow-up until (b)(6) 2014. Pt had discontinued use of lenses for a while, but returned to wearing them prior to visiting ecp and had same painful reaction to the lenses. Ecp states "cornea - same finding" presumably from a repeat staining test. Pt stated that this issue had occurred last year. On (b)(6) 2014, synergeyes contacted (b)(6), an office attendant for (b)(6), od, pc and obtained the following information: pt had recurring dry eyes.
Patient Sequence No: 1, Text Type: D, B5
[15339241]
During the investigation the following information was obtained: base curve measured by radius scope and power measured by lensmeter. Both bc and power wire found to be within specifications. No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00013 |
| MDR Report Key | 3916143 |
| Report Source | 05 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-05-19 |
| Date Added to Maude | 2014-07-08 |
| 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, DIRECTOR |
| 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 - AS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-06-06 |
| Returned To Mfg | 2014-05-19 |
| Model Number | AS7585-0750 |
| Lot Number | 055561 |
| Device Expiration Date | 2018-12-01 |
| 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 | 2014-06-06 |