MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-02-07 for MENICON EX-Z RIGID GAS PERMEABLE LENS manufactured by Menicon Co. Ltd..
[2533268]
The info was received from menicon's affiliate in (b)(6). A (b)(6) female pt had red eye and ocular irritation ou. The suspended contact lens wear and went to her general practitioner who prescribed tobramycin ointment. She was later seen by her ophthalmologist who switched the treatment to ciprofloxacin drops. The treatment time with each medication is unk but the total treatment time was for 20 days. No cultures were performed by either practitioner. Treatment has been discontinued, the condition has resolved and the pt has returned to a normal lens wearing schedule. It was the doctor's impression that the cause of the infection might be linked to poor adherence to lens care regimen and poor hygiene. The pt is using tap water to wash the lens case and used the case before it is completely dried and case was not changed regularly. Despite repeated requests, menicon's affiliate has not been able to obtain additional info other than the pt has returned to normal with no serious health consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614761-2012-00001 |
| MDR Report Key | 2445497 |
| Report Source | 01,08 |
| Date Received | 2012-02-07 |
| Date of Report | 2012-01-10 |
| Date of Event | 2011-12-20 |
| Date Mfgr Received | 2012-01-16 |
| Date Added to Maude | 2012-06-27 |
| 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 Street | 1840 GATEWAY DR, 2ND FLOOR |
| Manufacturer City | SAN MATEO CA 94404 |
| Manufacturer Country | US |
| Manufacturer Postal | 94404 |
| Manufacturer Phone | 6503781425 |
| Manufacturer G1 | MENICON HOLDINGS EUROPE |
| Manufacturer Street | 104 RUE MARTRE 33141401900 |
| Manufacturer City | CLICHY CEDEX 92583 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92583 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON EX-Z RIGID GAS PERMEABLE LENS |
| Generic Name | CONTACT LENS |
| Product Code | MWL |
| Date Received | 2012-02-07 |
| Lot Number | JNW1861T2 |
| Device Expiration Date | 2016-04-01 |
| 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 | MENICON CO. LTD. |
| Manufacturer Address | NAGOYA, AICHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-02-07 |