MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-11 for SYNERGEYES HYBRID CONTACT LENS CK25M-0475 manufactured by Synergeyes, Inc..
[16177187]
On (b)(6) 2014, synergeyes received a complaint wherein the patient (pt) sustained a corneal abrasion. Report stated: abrasion occurred in the left eye (os) a half hour after pick up. Pt was instructed to discontinue use of lenses and see ecp in two days' time. At the follow up appointment, dr. Stated "bearing could have caused abrasion. " on (b)(6) 2014, synergeyes attempted to contact the practice and a message was left with (b)(6) to have a contact lens dept rep return the call. On (b)(6) 2014, synergeyes received a call from (b)(4), the following info was obtained: by "bearing in the lens" the doctor meant that the lens fit too tightly.
Patient Sequence No: 1, Text Type: D, B5
[16316898]
During the investigation the following info was obtained: lens 1: lot: 058827, part number: ck25m-0475. Base curve was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within specs. Although deposits and smudges were noted on surface, both were removed by saline and were most likely due to regular pt use. No correlation was found between the alleged injury and the device history report. Lens 2: lot: 058827, part number: ck25m-0475. Base curve was measured by radius scope and power was measured by lensometer. Both bc and power were found to be within specs. Although deposits and smudges were noted on surface, both were removed by saline and were most likely due to regular pt use. No correlation was found between the alleged injury and the device history report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00020 |
| MDR Report Key | 4057965 |
| Report Source | 05 |
| Date Received | 2014-08-11 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-29 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2014-09-05 |
| 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 |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-08-11 |
| Returned To Mfg | 2014-07-29 |
| Model Number | CK25M-0475 |
| Lot Number | 058827 |
| Device Expiration Date | 2019-05-01 |
| 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 | 2014-08-11 |