MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-05 for SYNERGEYES HYBRID DAILY CONTACTS - PS PS8886-0175L2/H.10 manufactured by Synergeyes.
[22211500]
Second device returned: model #: ps888-0550l2, lot #: 057235, expiration date: 03/01/2019. During the investigation, the following information was obtained: for device 1 (lot #046764) base curve (bc) measured using radius scope and power measured using lensometer, both bc and power were found to be within specifications. No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history. For device 2 (lot #057235) base curve (bc) measured using radius scope and power measured using lensometer, both bc and power were found to be within specifications. No defects were noted on surface and no correlation was found between the alleged injury and the lens processing history. Conclusion: alleged corneal abrasion occurred during specified fitting period, possibly due to poor fit, and resolved with discontinuation of use. Attending ecp stated patient was using poor removal method, which may have contributed to the alleged injury. No defects were found and no correlation was found between the alleged injury and the lens processing history.
Patient Sequence No: 1, Text Type: N, H10
[22269008]
On (b)(4) 2014, synergeyes received a complaint wherein the patient sustained a corneal abrasion leading to iritis in os and od. Complaint stated: upon removal of lenses, patient had extreme discomfort which, according to the attending ecp, is possibly due to a poor insertion and removal technique, the patient used. Severe pain and photophobia followed, the patient's "staff" physician applied an eye patch to the od. Origin of pain and photophobia was found to be a corneal abrasion with subsequent iritis. Thereafter, the patient discontinued use of "all" contact lenses. On (b)(6) 2014, synergeyes contacted "(b)(6)", an office attendant for doctors (b)(6), and obtained the following information: 1) patient started wearing lenses on a saturday at work before (b)(6) 2014 and experienced pain. An on-site physician applied an eyepatch to od. Patient saw attending ecp on (b)(6) 2014 when vigamox was prescribed. 2) on (b)(6) 2014, patient returned to ecp with sore eyes, treated again with vigamox. The following day, (b)(6) 2014, patient tried to wear lenses again. Patient returned to ecp office on (b)(6) 2014 with same pain. Upon examination, attending ecp diagnosed patient with keratoconjunctivitis and iritis once again prescribing vigamox. 3) attending ecp determined that the contacts in question were a tight fit and that the patient used a poor removal technique, which may have contributed to the injury. 4) patient had lasik surgery in 1998, which is why the lenses were of the post surgery line of synergeyes products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005087645-2014-00012 |
| MDR Report Key | 3874023 |
| Report Source | 05 |
| Date Received | 2014-06-05 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-04-28 |
| Date Mfgr Received | 2014-05-19 |
| Date Added to Maude | 2014-06-17 |
| 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 HYBRID DAILY CONTACTS - PS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-06-05 |
| Returned To Mfg | 2014-05-19 |
| Model Number | PS8886-0175L2/H.10 |
| Lot Number | 046764/SEE H.10 |
| Device Expiration Date | 2017-09-01 |
| 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 |
| Manufacturer Address | CARLSBAD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-05 |