MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-20 for SYNERGEYES HYBRID CONTACT LENS SEE H-10 manufactured by Synergeyes, Inc..
[19724231]
On (b)(6) 2014, synergeyes received a complaint wherein the patient (pt) sustained corneal edema on right eye (od). Report stated: pt had corneal edema with giant papillary conjunctivitis (gpc) in both eyes (ou) due to contact lens (cl) use. On (b)(6) 2014, synergeyes contacted dr. (b)(6) regarding pt and the following information was obtained: on (b)(6) 2014, pt saw attending eye care professional (ecp) complaining of discomfort in ou but greater pain in od. Corneal edema found in od during examination. Steroid medication and muro 128 were prescribed. Gpc symptoms resolved with prescription of medication. Ecp believes cl to be cause of edema and that, "the injury was detrimental to the patient's health. " no recorded pre-existing conditions that could have caused or contributed to the event. Customer did not return problem lenses for inspection.
Patient Sequence No: 1, Text Type: D, B5
[19857901]
No information was given by ecp regarding which lenses caused the edema, therefore, we were unable to provide model number, lot number and expiration date nor could we provide the manufacture date. Problem lenses not returned, no inspection could be performed. Note by (b)(4), quality assurance, regulatory and clinical affairs: "per call (b)(4) 2014,: ecp reports that she believes the edema and gpc experienced by the patient are a threat to the patient's health and constitute an injury. " (b)(4) comments: corneal edema and gpc are not sight-threatening conditions and occur commonly with all contact lenses. They will resolve without sequelae after cl is removed and could have been caused by allergy, lenses, multipurpose solution, or a reaction to something else. Regardless, they would resolve spontaneously with removal of lenses if the etiology is the lenses. Not an injury. However, since doctor believes, firmly, that this is an injury, file mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00015 |
| MDR Report Key | 4013953 |
| Report Source | 05 |
| Date Received | 2014-06-20 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-06-02 |
| Date Added to Maude | 2014-08-19 |
| 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 CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-06-20 |
| Model Number | SEE H-10 |
| Lot Number | SEE H-10 |
| 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 | 2014-06-20 |