MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-22 for SYNERGEYES HYBRID CONTACT LENS DUH300 NA manufactured by Synergeyes, Inc..
[4091184]
Synergeyes determined within 30 days of receipt of the complaint that the event was not reportable. This decision was based on the information provided to synergeyes on (b)(6) 2013, wherein the patient experienced irritation, photophobia, watery eyes, and corneal abrasion/cell plus flare during the fitting process. These symptoms indicated that there was a fitting/non-adaptation issue and that the physician should have either tried a steeper diagnostic lens or discontinued attempting to fit a postsurgical eye with an ultrahealth lens. On (b)(6) synergeyes received information from the physician that the patient "had full-blown iritis, wit cells and flare. " receipt of this information changed the status of not reportable to reportable. Comments from discussion w/doctor on (b)(6) 2014: patient is post-rk in left eye and post-corneal graft in right eye. The doctor acknowledged that the ultrahealth lens is not indicated for postsurgical, but wanted to try it anyway.
Patient Sequence No: 1, Text Type: D, B5
[11490874]
On (b)(6)2013, the doctor fit an ultrahealth 300 vault diagnostic lens on the patient's right eye. Immediately the patient stated that the lens felt uncomfortable, but "not bad. " the right eye was watering. The lens was removed and the eye rinsed with saline. The doctor inserted an ultrahealth 350 vault diagnostic lens. The patient had the same response and exhibited mild spk, but not bad. The patient was willing to go home with lens. The patient returned the next day ((b)(6) 2013) with an irritated right eye and was photophobic. The doctor noted the iritis, with cells and flare, removed lens, and started durezol (steroid) and besivance (antibiotic). The patient returned on (b)(6) 2013 and it was noted that the patient's eye looked better with little straining and reduced iritis. The doctor suggested tapering the med regimen with the patient to return later. When patient was contacted a few days later ((b)(6) 2013) she declined further follow-up and stated that her eye was fine. On (b)(6) 2013, the patient returned to the doctor wearing her previous (non-ultrahealth) contact lens for her right eye. The patient's vision was good and the iritis, with cells and flare was completely healed. The doctor reported no further plans to fit the patient's right eye with an ultrahealth lens. Synergyes reminded the doctor that the ultrahealth lens is not indicated for postsurgical eyes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00003 |
| MDR Report Key | 3597077 |
| Report Source | 05 |
| Date Received | 2014-01-22 |
| Date of Report | 2014-01-21 |
| Date of Event | 2013-12-02 |
| Date Mfgr Received | 2013-12-03 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-01-30 |
| 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, DIR |
| 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 |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-01-22 |
| Model Number | DUH300 |
| Catalog Number | NA |
| Lot Number | 051160-1 |
| ID Number | NA |
| Device Expiration Date | 2013-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-01-22 |