MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-04-18 for SYNERGEYES HYBRID DAILY CONTACT LENS AS7787-0075 manufactured by Synergeyes, Inc..
[4441392]
On (b)(6)2014 synergeyes received a complaint from dr. (b)(6) regarding a pt who has keratoconus and meibomian gland dysfunction. It was reported that the pt's left eye sustained a corneal edema while wearing a synergeyes contact lens. The practice was contacted by synergeyes on (b)(6) 2014 for additional event info. The pt has been wearing the synergeyes contact lenses ordered through the (b)(6) center since 2010; the last order was shipped to the (b)(6) center on (b)(6) 2012. In (b)(6) 2013 the pt was seen by the dr. (b)(6) practice. New lenses were ordered by the practice using the pt's pre-existing prescription (ap7487-0075ct) changing the rx from an ap to an as and power from -0. 75 to -0. 50. The pt's k readings and topographical measurements were not taken at the time of the examination for the new lens order. On (b)(6) 2013 synergeyes shipped an as7487-0050 to the practice as a "first order" which was dispensed on (b)(6)2013. On (b)(6) 2013 synergeyes shipped an as7487-0075 to the practice as an "exchange prescription" and on (b)(6) 2013 the two pack completion set was shipped. The lenses were dispensed on (b)(6) 2013. Post dispensing and prior to the pt's office visit to the practice on (b)(6)2014, the pt's left eye became irritated. In an effort to diagnose the irritation the pt decided to remove the current lens and replace with the lens from the 2 pack completion; the irritation did not change. In response to the irritation, dr. (b)(6)instructed the pt to use warm compresses and optifree drops. The pt's wear schedule was changed to wear the lens for no more than 8 hours a day, with 1 hour breaks and only wear the lenses when the eyes are not red or irritated. The pt was seen by the practice on (b)(6) 2014 wherein dr. (b)(6) determined that the pt had acute conjunctivitis. The practice also stated that the pt had moderate grade conjunctiva hyperemia bulbar 2+, corneal edema, and stromal thinning. No meds were prescribed during the (b)(6) 2014 office visit. On (b)(6) 2014 the pt was seen by the dr. (b)(6) for a follow up.
Patient Sequence No: 1, Text Type: D, B5
[11826294]
Two lenses were associated with the alleged injury. Lens 1. 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. Lens 2: model#: as7487-0075, lot#: 054921, expiration date: 11/16/2018. Manufacture date: 12/16/2013. 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 | 3005087645-2014-00010 |
| MDR Report Key | 3775826 |
| Report Source | 99 |
| Date Received | 2014-04-18 |
| Date Mfgr Received | 2014-04-02 |
| Device Manufacturer Date | 2013-08-09 |
| Date Added to Maude | 2014-04-29 |
| 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 | 2014-04-02 |
| Model Number | AS7787-0075 |
| Lot Number | 052463 |
| Device Expiration Date | 2018-07-09 |
| 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 |