MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-30 for SYNERGEYES HYBRID CONTACT LENS UH55M-0550 manufactured by Synergeyes, Inc..
[18368873]
On (b)(6) 2014, synergeyes received a complaint wherein the patient (pt) allegedly sustained a corneal abrasion/ulcer. Report stated: the pt was allegedly seen by the dr and prescribed e-mycin opthalmic ointment for the left yes (os). The next day the pt was seen by an ophthalmologist and diagnosed with a corneal abrasion in the os. Pt was seen again on (b)(6) 2014 by attending eye care profession (ecp) dr. (b)(6). Pt wanted to discontinue use of contact lenses and continued follow-up with his ophthalmologist. On (b)(6) 2014, synergeyes attempted to contact (b)(6) by phone and was directed by an office assistant at (b)(6) to get in contact with either (b)(6) or (b)(6). Left a message with the office assistant to have (b)(6) contact synergeyes. On (b)(6) 2014, synergeyes contacted (b)(6) and the following information was obtained: pt went to er on (b)(6) 2014. Pt saw er because of difficulty removing the contact lens (cl). Pt saw an ophthalmologist and was diagnosed with a corneal ulcer. According to the ecp, the pt did not have an unusual insertion or removal technique. The pt stopped using cl's immediately after the trip to the er. The attending ecp had no current information on the status of the pt due to discontinued use of all contact lenses.
Patient Sequence No: 1, Text Type: D, B5
[18425289]
During the investigation, the following information was obtained: base curve as measured by radius scope and power eas measured by lensometer. Both bc and power were found to be within specifications. Though scratches were found on the surface, they are consistent with regular pt use. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00019 |
| MDR Report Key | 4020642 |
| Report Source | 05 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-29 |
| Date of Event | 2014-07-11 |
| Date Mfgr Received | 2014-07-20 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-08-20 |
| 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, QA DIRECTOR |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604449363 |
| 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 | 2014-07-30 |
| Model Number | UH55M-0550 |
| Lot Number | 058788 |
| Device Expiration Date | 2019-05-01 |
| 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, INC. |
| Manufacturer Address | CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-30 |