MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-16 for SYNERGEYES HYBRID CONTACT LENS AS7181-0800 manufactured by Synergeyes.
[4763696]
On (b)(6) 2014, synergeyes received a complaint wherein the reasons for return were neovascularization and moderate edema. Report stated, "after trying lens pt came in with redness, pain, mild neo temporal, and moderate edema in the right eye. " ecp described the treatment as well: "muro 128 and steroid drop... Refit to duette. " on (b)(6) 2014, (b)(4) of synergeyes contacted "(b)(6)" at (b)(6) and the following info was obtained: pt. General med history is keratoplasty corneal transplant. Pt had been wearing synergeyes a lens and developed corneal neovascularization (penetrating keratoplasty) which doctor believes is due to lens. Ecp switched to ks lens; did not work. Switched to duette lens; neovascularization resolved and pt is ok now. No medication or other med attention was needed to resolve the neovascularization.
Patient Sequence No: 1, Text Type: D, B5
[12200160]
During the investigation, the following info was obtained; base curve was obtained: base curve was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within specifications. No obvious defects were noted on surface. No correlation was found between the alleged injury and the device history report. A note from (b)(4): "neovascularization is a common sequelae to corneal transplant and a synergeyes a lens is not indicated for such use. Nonetheless, the doctor believes the condition was caused by the off-label use of the synergeyes a lens. Synergeyes disagrees with this conclusion since this finding would normally be considered indicative of the need to discontinue wear of the contact lens and not a frank injury. However, since the doctor believes this is a lens-related injury, file mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00023 |
| MDR Report Key | 4109713 |
| Report Source | 05 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-12 |
| Date of Event | 2014-03-19 |
| Date Mfgr Received | 2014-09-05 |
| Device Manufacturer Date | 2014-03-25 |
| Date Added to Maude | 2014-09-24 |
| 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, QA DIR |
| 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 | 2014-09-16 |
| Returned To Mfg | 2014-09-05 |
| Model Number | AS7181-0800 |
| Lot Number | 056999 |
| Device Expiration Date | 2019-02-01 |
| 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 | 2014-09-16 |