MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-23 for MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS * manufactured by Menicon Co. Ltd..
[308678]
The pt participating in the post approval study of the menicon z rgp contact lens for up to 30 days/29 nights of extended wear was seen by a doctor (o. D. ) in 2003 with an epithelial defect with surrounding edema. The pt injured their eye while removing their lens to remove debris from their eye. The pt was treated with ciloxan by the doctor on that date. The pt was seen again by the doctor two days later and was improving. The doctor recommneded that the pt leave their lenses out for another 4 days. The pt returned to the doctor four days later and their condition had resolved. The doctor recommneded that the pt return to daily wear for a week, then returned to extended wear. The doctor saw the pt for a regular visit in march 2004 and the pt was doing fine with excellent vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003515967-2004-00001 |
| MDR Report Key | 522341 |
| Date Received | 2004-04-23 |
| Date of Report | 2004-04-01 |
| Date of Event | 2003-07-29 |
| Report Date | 2004-04-01 |
| Date Reported to Mfgr | 2004-04-01 |
| Date Added to Maude | 2004-04-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS |
| Generic Name | RGP CONTACT LENS |
| Product Code | MWL |
| Date Received | 2004-04-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 511469 |
| Manufacturer | MENICON CO. LTD. |
| Manufacturer Address | * NAGOYA, AICHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-23 |