MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-27 for MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS * manufactured by Menicon Co. Ltd..
[376032]
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 dr (o. D. ) in 2003 with a small central abrasion on their right cornea for which the pt had no sensation. The dr had the pt discontinue wear of the menicon z lenses for 3 days and, then, re-start their extended wear schedule. After 12 weeks, the pt returned to the dr saying that their right eye was uncomfortable and the pt had some corneal epithelial defects which over the course of the next 3 weeks did not improve. A new pair of menicon z lenses were dispensed in 2004 but this epithelial defect on the pt's right cornea did not improve. In 2003, the dr discontinued the pt from the post approval study due to the above epithelial defect. The pt got back to daily wear schedule with other material rgp contact lens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003515967-2004-00003 |
| MDR Report Key | 559601 |
| Date Received | 2004-04-27 |
| Date of Report | 2004-04-01 |
| Date of Event | 2003-08-04 |
| Report Date | 2004-04-01 |
| Date Reported to Mfgr | 2004-04-01 |
| Date Added to Maude | 2004-12-15 |
| 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 | MLW |
| Date Received | 2004-04-27 |
| 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 | 549299 |
| Manufacturer | MENICON CO. LTD. |
| Manufacturer Address | * NAGOYA, AICHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-27 |