MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-12 for SYNERGEYES HYBRID CONTAC LENS KS6985-0800 manufactured by Synergeyes, Inc..
[5776424]
On (b)(4) 2015, synergeyes received a complaint wherein the reason for return was ulcer. The report stated "the patient claims opened new vial because they had dropped the previous lens in the sink and didn't have time to clean. New lens was uncomfortable from start of wear however, the patient continued to wear the lens. Next day eye still hurt, patient went to urgent care facility. " the ecp continues, "patient does have keratoconus in the os. " ecp states that patient is blind in od. Ecp also claims, "the patient did not have any pain or irritation in eye from wearing original lens, but started to feel foreign body sensation and pain immediately following insertion of the 2nd lens and was diagnosed with corneal ulcer two days later. " the report claims that discontinuation of the lens, antibiotic drops, artificial tears, oral pain medication, and use of sunglasses is all therapeutic treatment. The ecp is not specific as to which antibiotic drops were prescribed. Finally it is indicated that although the ulcer has resolved, a secondary complication "small corneal scar inferior to visual axis in os" arose. Between (b)(6) 2015 three (3) attempts were made to contact the ecp. On (b)(6) 2015, contact was made with the attending physician and the following information was obtained: ecp is unsure whether medication was prescribed at urgent care facility. Vigamox was the antibiotic treatment administered. Ecp is unsure of the oral pain medications dispensed. Ulcer has cleared and patient has a small residual corneal scar interior to visual axis. Patient has returned to lens wear using the replacement lens with no issues.
Patient Sequence No: 1, Text Type: D, B5
[13445047]
During the investigation the following information was obtained: base curve was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within specifications. During surface inspection, the lens was able to wet properly and although two known issues were identified, both passed the manufacturing specifications and are unlikely to have contributed to the alleged injury. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2015-00004 |
| MDR Report Key | 4768329 |
| Report Source | 05 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-05-11 |
| Date of Event | 2015-03-20 |
| Date Mfgr Received | 2015-04-14 |
| Device Manufacturer Date | 2015-01-29 |
| Date Added to Maude | 2015-05-14 |
| 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 CONTAC LENS |
| Product Code | HQD |
| Date Received | 2015-05-12 |
| Returned To Mfg | 2015-04-14 |
| Model Number | KS6985-0800 |
| Lot Number | 062909 |
| Device Expiration Date | 2020-01-01 |
| 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 | 2015-05-12 |