MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-27 for SYNERGEYES KC HYBRID DW LENS FOR KEARTOCONUS KS6382-1300CT manufactured by Synergeyes, Inc..
[3969899]
On (b)(6) 2013, synergeyes received a complaint stating that a pt's "2nd lens of 2 pack caused irritation after 2-3 hours of wear time. Pt removed cl and irritation increased overnight. Pt presented to od with corneal ulcer and corneal apex". The pt's pre-existing condition contributed to the injury as the pt had an unsuccessful outcome during lasik surgery along with a history of advanced keratoconus. The pt wore this new synergeyes lens (shipped on (b)(4) 2013) and found that the lens irritated his eye. An eye care professional at the od office instructed the pt to discontinue the use of the new lens. The pt went back to wearing the previously issued lens shipped to the pt on (b)(4) 2012 (ks6382-1300; lot number 046740) and reported that the lens did not cause any irritation. On (b)(6) 2013, the pt was seen by an od. It was stated that the pt had a corneal abrasion that was turning into an ulcer. The pt was instructed to discontinue the use wearing the lens for several days. On (b)(6) the od saw the pt and treated the pt for a corneal ulcer. The treatment included: verbal instruction to discontinue the use of the lens, pt was to wear an orthoptic eye patch, and take the prescribed moxera (moxifloxacin hcl; antibiotic). On (b)(6) 2013, the pt returned to the od wherein it was determined that the pt's ulcer had healed.
Patient Sequence No: 1, Text Type: D, B5
[11302073]
Eval code: the lens was inspected for surface defects; there were no obvious defects found on the lens. The lens was measured for base curve; the measured base curve was within the spec for a 6. 3 base curve. The lens was measured for power; the measured power was within the spec for a -13. 00 power. The review of the associated device history record did not indicate any processing or qc issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2013-00014 |
| MDR Report Key | 3514475 |
| Report Source | 05 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-10-28 |
| Date Mfgr Received | 2013-11-08 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2013-12-16 |
| 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 KC HYBRID DW LENS FOR KEARTOCONUS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2013-11-27 |
| Returned To Mfg | 2013-11-08 |
| Model Number | KS6382-1300CT |
| Lot Number | 051501 |
| Device Expiration Date | 2018-05-01 |
| 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 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-27 |