MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2014-10-10 for SYNERGEYES HYBRID CONTACT LENS CK30S-0225 manufactured by Synergeyes, Inc..
[19297352]
On (b)(6) 2014, synergeyes received a complaint directly from a patient wherein the reason for return was an er visit by the patient (pt) because pt could not remove the contact lens from their left eye (os). Pt sustained a corneal abrasion to the os during removal process. In the report it was stated "... The pt contacted 'his doctor' and was instructed to go to the emergency room (er) to have the lens removed. The er couldn't irrigate it out and used a whole 'iv bottle' full of saline. The er doctor had to break the lens up into pieces to remove it. The pt now has a 'severe' corneal abrasion and is 'unable to see out of his left eye'. " it was also reported that there were no issues removing the lens from the pt's right eye (od). Between (b)(6) 2014, four attempts were made to contact the ecp. On (b)(6) 2014, dr. (b)(6) was contacted and the following information was exchanged: dr. (b)(6) was not the doctor contacted by the pt. Therefore, dr. (b)(6) has no information on the current status of the pt. Patient had not been in ecp's office since (b)(6) 2014 at which time the pt had no issues. According to the ecp, the pt has worn this type of lens for two years or more with no prior issues. Dr. (b)(6) will attempt to contact pt and will inform synergeyes of any updates.
Patient Sequence No: 1, Text Type: D, B5
[19369109]
Synergeyes cannot confirm that the patient reported statement "unable to see out of left eye" is a definable medical condition. Therefore, the patient reported statement is considered by synergeyes to be a clinical incident, until determined by a medical physician. The process review investigation determined that there was no correlation between the alleged injury and the lens processing history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00024 |
| MDR Report Key | 4172039 |
| Report Source | 04,05 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-01-09 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-09-18 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-10-16 |
| 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 | 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 |
| Product Code | HQD |
| Date Received | 2014-10-10 |
| Model Number | CK30S-0225 |
| Lot Number | 056566 |
| Device Expiration Date | 2014-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-10-10 |