MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-29 for SYNERGEYES HYBRID CONTACT LENS UH25M-0650 manufactured by Synergeyes.
[4853859]
On (b)(6) 2014, synergeyes received a complaint wherein the reasons for return were abrasion and infection. Report stated, "corneal abrasion sustained infection treatment with antibiotic drops" also included in the report was the information that the patient had the pre-existing condition of keratoconus and that the ecp felt that the pt contributed to the event by wearing a torn lens. On (b)(6) 2014, synergeyes contacted (b)(6), an office attendant for dr. (b)(6) and the following information was obtained. Maxitrol was the anti-biotic medication prescribed. Patient has new pair of lenses and is not having any issues.
Patient Sequence No: 1, Text Type: D, B5
[12431901]
During the investigation the following information was obtained: base curve was measured by radioscope and power was measured by lensometer. Both bc and power were found to be within specifications. Although the skirt was found to be cloudy, it was consistent with a known reaction to the use of clearcare cleaning solution. A smudge was found on the base curve of the lens, however, it was removed by use of saline and a swab. A scarch was found on the rigid gas permeable portion of the lens, this is consistent with regular pt use. None of these surface observations are considered device malfunctions. Although the ecp suspected that a torn skirt might be responsible for the abrasion, no tear was found. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00022 |
| MDR Report Key | 4072059 |
| Report Source | 05 |
| Date Received | 2014-08-29 |
| Date of Report | 2014-08-28 |
| Date of Event | 2014-07-29 |
| Date Mfgr Received | 2014-08-18 |
| Device Manufacturer Date | 2014-04-03 |
| Date Added to Maude | 2014-09-10 |
| 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 CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-08-29 |
| Returned To Mfg | 2014-08-18 |
| Model Number | UH25M-0650 |
| Lot Number | 057160 |
| Device Expiration Date | 2019-03-01 |
| 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 | 2014-08-29 |