MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2010-06-13 for MENICON Z RIGID GAS PERMEABLE LENS manufactured by Menicon Co. Ltd..
[1537114]
The info was received from menicon's affiliate in (b)(4). An ophthalmologist reported to (b)(6). A patient developed corneal abscess in the right eye while wearing menicon z in extended wear basis. Based on further investigation done by the affiliate, (b)(6)2010, a corneal abscess was seen in pt's eye and pt was treated with rifamycin, desomedine, xylocaine and topical corticosteroids for 5 weeks, (b)(6)2010. There was a culture positive delftia acidovorans. He was asked to come twice a week f/u. After 5 weeks, the visual acuity has decreased to 06/10 (initial 10/10). The doctor's comment is that it was linked to a bad hygiene and handling of the patient. No add'l info available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614761-2010-00002 |
| MDR Report Key | 1721584 |
| Report Source | 00,01 |
| Date Received | 2010-06-13 |
| Date of Report | 2010-05-13 |
| Date of Event | 2010-03-26 |
| Date Mfgr Received | 2010-05-13 |
| Date Added to Maude | 2010-06-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1840 GATEWAY DRIVE, 2ND FL. |
| 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 |
| 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 Z RIGID GAS PERMEABLE LENS |
| Generic Name | RGP CONTACT LENS |
| Product Code | MWL |
| Date Received | 2010-06-13 |
| Lot Number | EBT5555T2 |
| 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 | 2010-06-13 |