MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-05 for SYNERGEYES HDS HYBRID CONTACT LENSES CK45S-1650 NA manufactured by Synergeyes, Inc..
[4104905]
On (b)(4) 2013, synergeyes received a complaint that a patient had a corneal abrasion. Patient was seen by the practitioner on (b)(6) 2013 for pain and redness od. Onset a few days prior. It was determined that he developed an abrasion from the clearkone lens. Patient was treated with tobradex and the abrasion received. Spoke with doctor. Told him we believe patient mixed lenses and wore the ck20s-0900. Since a ck45s-1650 is the correct-fit lens for this eye, it is likely that abrasion is due to patient wearing wrong lens. Lens we received verified to be have 200 vault and -9. 00 d event though it was in a vial labeled as ck45s-1650. Doctor said he returned lens 200 vault lens because of a tear in lens (cause of tear not known) and the tear caused abrasion which was treated with tobradex. Told him we can't verify tear as qc noted no defects. It is possible that patient did mix up lenses but that cannot be verified. Od believes that cause of abrasion is a torn lens due to an unknown cause, and we cannot ascertain exactly what happened here, so mdr filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005087645-2013-00015 |
| MDR Report Key | 3519152 |
| Report Source | 05 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-12-05 |
| Date of Event | 2013-11-04 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-12-16 |
| 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 | STEVE ZIEMBA, VP |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604449687 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES HDS HYBRID CONTACT LENSES |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2013-12-05 |
| Returned To Mfg | 2013-11-04 |
| Model Number | CK45S-1650 |
| Catalog Number | NA |
| Lot Number | 045279 |
| ID Number | NA |
| Device Expiration Date | 2017-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2013-12-05 |