MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-15 for SYNERGEYES HDS HYBRID LENSES KS6382-0950 NA manufactured by Synergeyes, Inc..
[21110347]
On (b)(6) 2013, synergeyes received a report wherein a patient who has keratoconus, incurred a corneal abrasion within one day of wearing the lens. As reported, the practitioner treated the abrasion with besivance antibiotic ophthalmologic drops. The abrasion was found to have resolved within 7 days and was considered by the practitioner to be a temporary condition. The physician stated that they looked at the lens under magnification and observed scratches on the soft skirt which the physician felt caused the abrasion. The patient received a new lens and is wearing the lens with no discomfort or irritation noted. Synergeyes inspected the surface of the returned lens and determined that there were superficial scratches noted on the skirt of the lens. However, the scratches are passable by manufacturing standards.
Patient Sequence No: 1, Text Type: D, B5
[21279721]
During the complaint investigation the following information was obtained: lens surface was inspected using an optical microscope. There were superficial scratches noted on the skirt of the lens. However, the scratches are passable by manufacturing standards. Base curve was measured using a radiuscope. The lens' measured parameter was within the lens' design specifications. Power was measured using a lensometer. The lens' measured parameter was within the lens' design specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00002 |
| MDR Report Key | 3591367 |
| Report Source | 05 |
| Date Received | 2014-01-15 |
| Date of Report | 2014-01-15 |
| Date of Event | 2013-12-03 |
| Date Mfgr Received | 2013-12-23 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-01-27 |
| 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, DIRECTOR |
| 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 HDS HYBRID LENSES |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-01-15 |
| Returned To Mfg | 2013-12-23 |
| Model Number | KS6382-0950 |
| Catalog Number | NA |
| Lot Number | 052755 |
| ID Number | NA |
| Device Expiration Date | 2018-07-01 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-15 |