MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-16 for MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS * manufactured by Menicon Co., Ltd..
[296403]
The pt who has been participating in the post approval study of menicon z rgp contact lens for up to 30 days/29 nights of continuous wear was seen by a dr with an injury to right eye secondary to being hit in the eye with a blanket. The pt entered wearing menicon z contact lenses, va 20/20 od, 20/20 os. Slit lamp examination showed grade 1 (minimal) cell and flare in the right eye. The pt was given cyclopentalate bid and predforte qid. The pt was examined by the dr again in 5/2003. All results were negative. The cyclopentalate was discontinued and the predforte was tapered to discontinuation. The pt continued to wear the menicon z lenses for extended wear during this time without problems. The pt continues to wear the lenses for extended wear and remain in the post approval study of the menicon z rgp contact lens for up to 30 days/29 nights of extended wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003515967-2003-00001 |
| MDR Report Key | 502195 |
| Date Received | 2003-12-16 |
| Date of Report | 2003-10-17 |
| Date of Event | 2003-05-22 |
| Date Facility Aware | 2003-10-17 |
| Report Date | 2003-10-17 |
| Date Reported to Mfgr | 2003-10-17 |
| Date Added to Maude | 2003-12-23 |
| 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 | 2003-12-16 |
| 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 | 490968 |
| Manufacturer | MENICON CO., LTD. |
| Manufacturer Address | * NAGOYA, AICHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-12-16 |