MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,02,03 report with the FDA on 2010-04-29 for MENICON Z RIGID GAS PERMEABLE LENS MATERIAL manufactured by Menicon Co. Ltd..
[18111654]
The following information became available following a literature review as part of the annual report. The initial reporter states that the patient participated in the study conducted in (b) (6) for (b) (4) manufactured in (b) (4) material. At the time of 6 month follow up in (b) (6), 2008, a peripheral ulcer was seen in his left eye and patient was treated with tobradex for 7 days. After one month, the ulcer had resolved completely and there was no corneal scarring from the peripheral ulcer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614761-2010-00001 |
| MDR Report Key | 1675185 |
| Report Source | 00,01,02,03 |
| Date Received | 2010-04-29 |
| Date of Report | 2010-04-23 |
| Date of Event | 2008-11-01 |
| Date Mfgr Received | 2010-04-15 |
| Date Added to Maude | 2010-05-10 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 1840 GATEWAY DRIVE 2ND FLOOR |
| Manufacturer City | SAN MATEO CA 94404 |
| Manufacturer Country | US |
| Manufacturer Postal | 94404 |
| Manufacturer Phone | 6503781425 |
| Manufacturer G1 | MENICON CO., LTD. |
| Manufacturer Street | 21-19 AOI 3-CHOME, NAKA-KU |
| Manufacturer City | NAGOYA, AICHI 460-0006 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 460-0006 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON Z RIGID GAS PERMEABLE LENS MATERIAL |
| Generic Name | RGP CONTACT LENS MATERIAL |
| Product Code | MWL |
| Date Received | 2010-04-29 |
| 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 | 2010-04-29 |