MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-17 for MENICON Z STANDARD NA manufactured by Menicon U.s.a..
[100224]
Irritation to the patients eye. No permanent or serious injury was done. The "drill dot" applied to the contact lens for identification, was done incorrectly. This causes a "burr" to the lens and it rubbed on the patients eye resulting in an irritation. No treatment was given, just exam by dr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950360-1998-00006 |
| MDR Report Key | 187806 |
| Report Source | 05 |
| Date Received | 1998-09-17 |
| Date of Report | 1998-09-11 |
| Date of Event | 1997-12-11 |
| Date Mfgr Received | 1997-12-19 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-09-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON Z |
| Generic Name | RIGID GAS PERMEABLE LENS |
| Product Code | HPX |
| Date Received | 1998-09-17 |
| Returned To Mfg | 1997-12-19 |
| Model Number | STANDARD |
| Catalog Number | NA |
| Lot Number | Z1033Q-50 |
| ID Number | 334902 INVOICE |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182523 |
| Manufacturer | MENICON U.S.A. |
| Manufacturer Address | 333 WEST PONTIAC WAY CLOVIS CA 93612 US |
| Baseline Brand Name | MENICON Z |
| Baseline Generic Name | RIGID GAS PERMEABLE LENS |
| Baseline Model No | STANDARD |
| Baseline Catalog No | NA |
| Baseline ID | 334902 INVOICE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-17 |