MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-09 for SYNERGEYES HYBRID CONTACT LENS - KS KS6785-1450 manufactured by Synergeyes.
[4565747]
On (b)(4) 2014, synergeyes received a complaint wherein pt sustained a corneal ulcer in the right eye (od). Pt also experienced "slight irritation. " attending eye-care professional (ecp) prescribed tobradex for symptoms in the left eye (os). Complaint states that symptoms surfaced (b)(6) 2014, however "all symptoms have been resolved as of now. " wherein, "now" refers to (b)(6) 2014. From (b)(6) 2014, several attempts were made to obtain additional event information from ecp. On (b)(6) 2014, synergeyes spoke with dr (b)(6) regarding the event and pt. The following was disclosed: pt has a history of over wearing lenses. For example: pt wore last set of synergeyes lens for longer than one year, when the recommended length is 6 months, the lenses mentioned were ordered (b)(6) 2009. New lenses ordered in the same parameters on (b)(6) 2014 were uncomfortable for pt and pt developed redness and irritation with pain greater in od than in os. At a follow up visit, pt exhibited a "mechanical" sterile ulcer in the right eye just outside the junction. This cleared completely with treatment. A technician from the ecp practice called synergeyes consultation on (b)(6) 2014 and inquired about os lens turning eye "red. " synergeyes consultant instructed lab tech to switch lenses to see if problem followed lens to od or remained only in os. As instructed by dr (b)(6) this was never done. Instead, dr (b)(6) returned lenses and reordered the same prescription (rx) for both eyes, to verify if original lenses were "bad". Os rx was ordered on (b)(6) 2014 and od rx on (b)(6) 2014. Pt is doing well with new lenses for both eyes.
Patient Sequence No: 1, Text Type: D, B5
[12100241]
Second device returned: model # ks6785-1550, lot #: 052049, expiration date: 06/01/2018, manufacture date: 07/01/2013. During the investigation, the following information was obtained. Device 1: base curve measured by radius scope and power measured by lensometer, both bc and power were 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. Device 2: base curve measured by radius scope and power measured by lensometer. Both bc and power were 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 | 3005087645-2014-00014 |
| MDR Report Key | 3883639 |
| Report Source | 05 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-06-06 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-05-12 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-06-20 |
| 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 - KS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-06-09 |
| Returned To Mfg | 2014-05-12 |
| Model Number | KS6785-1450 |
| Lot Number | 056131 |
| Device Expiration Date | 2019-01-01 |
| 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 | 2014-06-09 |