MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-03 for SYNERGEYES HDS HYBRID CONTACT LENSES KS6185-1300 NA manufactured by Synergeyes, Inc..
[4301543]
On (b)(6) 2014, synergeyes received information from a customer that a patient "had to go to the emergency room because the lens tore in her eye. " synergeyes instructed the customer to send the lens and the product complaint form to synergeyes. The lenses and form were received on (b)(4). The form was completed by the same individual who originally contacted synergeyes. The form indicated that there was no patient injury as a result of the emergency room visit. Synergeyes made 6 attempts to obtain additional information from the practice with no response from the practice until (b)(6)2014 when synergeyes was able to discuss the event with dr. (b)(6) at (b)(6) optometry. Dr. (b)(6) provided the following event information: other than an office staff member who reported the event, no one else at (b)(6) optometry knew about the event. The patient was last seen by the practice on (b)(6) 2013 for a routine check-up; with no issues identified during the visit. The patient winters in (b)(6), and that perhaps the patient went to an emergency room in (b)(6). Dr. (b)(6) stated that she would attempt to contact the patient to gather additional information. Based on the information provided, synergeyes can neither determine the root cause of the issue nor determine if an injury actually occurred. Synergeyes has insufficient information to determine if the synergeyes lens caused or contributed to the patient seeking assistance at an emergency room. None-the-less, since the information received is unclear and potentiallly incomplete, synergeyes has decided to file this mdr.
Patient Sequence No: 1, Text Type: D, B5
[11551769]
The lens was received torn. It is not known when the tear occurred as tears can be a manifestation of patient handling and use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00005 |
| MDR Report Key | 3676728 |
| Report Source | 05 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-28 |
| Date Mfgr Received | 2014-02-04 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-03-14 |
| 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, 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 CONTACT LENSES |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-03-03 |
| Returned To Mfg | 2014-02-14 |
| Model Number | KS6185-1300 |
| Catalog Number | NA |
| Lot Number | 048870 |
| Device Expiration Date | 2018-01-01 |
| 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 | 2014-03-03 |