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 SA79F+0775 manufactured by Synergeyes, Inc..
[4433715]
On (b)(6) 2014, synergeyes consultation received a call from dr. (b)(6) regarding a pt who sustained a corneal ulcer on the os while wearing a synergeyes contact lens. Dr. (b)(6) was contacted by synergeyes on (b)(6) 2014 for additional event info. On (b)(4) 2014, ordered sa79f+0775 (os) for the pt. The lenses were shipped to the practice on (b)(6) 2013 and were dispensed by dr. Post dispensing the pt felt that the os lens was irritating the left eye, but continued to wear the lens for the 20/30 visual acuity the lens provided. Dr. (b)(6) saw the pt approx 1 week after dispensing the lens. The pt wore the lens to the examination and the lens remained on the pt during the visual examination. Dr. (b)(6) stated that the os eye locked irritated, but no abrasion was indicated during the visual examination. The pt was instructed to discontinue the use of the lens until symptoms subsided. On (b)(6) 2014, the pt returned to the practice still wearing the os lens. Dr. (b)(6) stated that the pt continued to wear the lens even after being advised to discontinue the use of the lens. During the subsequent visual examination dr. (b)(6) discovered a minor corneal ulcer on the pt's os; para-center and interior, with abrasions around the ulcer. Dr. (b)(6) stated that in response to the lens irritating the left eye, the pt rubbed the eye to relieve the irritation. The pt demonstrated the rubbing "technique" which consisted of putting pressure on the lens and vigorously rubbing the lens eye. Dr. (b)(6) further stated that this rubbing technique likely irritated the left eye, ultimately causing the ulcer. Dr. (b)(6) instructed the pt to discontinue the use of the lens and prophylactically prescribed ciloxan to treat the ulcer. Dr. (b)(6) concluded that the lens contributed to the event as cascading effect; if the pt had not worn the lens, the eye would not have been irritated, causing her to rub her eye.
Patient Sequence No: 1, Text Type: D, B5
[11875016]
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 radioscope. 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 | 3005087645-2014-00008 |
| MDR Report Key | 3775827 |
| Report Source | 05 |
| Date Received | 2014-04-18 |
| Date of Report | 2014-04-08 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-17 |
| Device Manufacturer Date | 2013-11-07 |
| 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 | 2014-04-17 |
| Model Number | SA79F+0775 |
| Lot Number | 054107 |
| Device Expiration Date | 2018-10-07 |
| 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 |