MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-12-04 for ATLAS CORNEAL TOPOGRAPHY SYSTEM 992 992-02 manufactured by Carl Zeiss Meditec Inc.
[299262]
The reporter; an attorney, represeting a patient stated that the patient had lasik surgery on both eyes in 2000. Prior to surgery, the user facility evaluated the patient for candidacy for surgery, including evaluation with the subject device. Since the surgery, the patient alleges injuries and damages to their eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2002-00004 |
| MDR Report Key | 431525 |
| Report Source | 04 |
| Date Received | 2002-12-04 |
| Date of Report | 2002-11-25 |
| Date of Event | 2000-08-18 |
| Report Date | 2002-11-25 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2002-12-10 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574180 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATLAS CORNEAL TOPOGRAPHY SYSTEM |
| Generic Name | CORNEAL MAPPER |
| Product Code | HJB |
| Date Received | 2002-12-04 |
| Model Number | 992 |
| Catalog Number | 992-02 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 420505 |
| Manufacturer | CARL ZEISS MEDITEC INC |
| Manufacturer Address | 5160 HACIENDA DR. DUBLIN CA 94568 US |
| Baseline Brand Name | STLOS CORNEAL TOPEGEOPHY SYSTEM |
| Baseline Generic Name | CORNEAL MAPPER |
| Baseline Model No | 992 |
| Baseline Catalog No | 992-02 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-12-04 |