MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-18 for SYNERGEYES HYBRID DAILY CONTACT LENS KS6585-0750 manufactured by Synergeyes, Inc..
[4684005]
On (b)(4) 2014 synergeyes received a complaint from (b)(6) regarding pt with keratoconus who had sustained a corneal abrasion/edema while wearing synergeyes contact lenses. The (b)(6) was contacted on (b)(4) 2014 for additional event info. In response to os irritation, the pt went to ophthalmologist dr (b)(6). Dr (b)(6) treated the pt's symptoms as an infection. Moreover, dr (b)(6) stated that the irritation was lens related and sent the pt back to vision source for a follow up. Vision source did not have any additional info regarding date, treatment, or medications administered by dr (b)(6). On (b)(6) 2014 the pt was seen by (b)(6) for a follow up with dr (b)(6) who instructed the pt to discontinue use of the lens. Dr (b)(6) then advised the pt to change their storage and cleaning solution to clearcare to eliminate it as the source of the os irritation. Dr (b)(6) stated in the pt's record that the irritation and subsequent corneal abrasion/ edema were due to apical touching of the os lens on the cornea. On (b)(6) 2014 on further issues.
Patient Sequence No: 1, Text Type: D, B5
[11963263]
During the investigation the following info was obtained: lens surface was inspected using an optical microscope. No surface defects were detected. Base curve was measured using a radiuscope. The lens' measured parameter was within the lens design specification. Power was measured using a lensometer. The lens' measured power was within the lens design specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00009 |
| MDR Report Key | 3848414 |
| Report Source | 05 |
| Date Received | 2014-04-18 |
| Date of Report | 2014-04-09 |
| Date of Event | 2014-03-21 |
| Device Manufacturer Date | 2013-07-29 |
| Date Added to Maude | 2014-06-05 |
| 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 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 DAILY CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-04-18 |
| Returned To Mfg | 2014-03-30 |
| Model Number | KS6585-0750 |
| Lot Number | 052266 |
| Device Expiration Date | 2018-06-29 |
| 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, INC. |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-18 |