MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-24 for HUMPHREY INSTRUMENT 820 820-4152 manufactured by Zeisis Humphrey System.
[227258]
On august 7, 2001, it was discovered that pt would need surgery to replace lens that was inserted in the pt's left eye. Vision in left eye was 20/70 pre operative. Vision in left eye was 20/400. Pre-operative axial length was 24. 31. Recheck of axial length was 22. 99. Using the same ultrasonic biometer. Calibration was checked and was correct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 349265 |
| MDR Report Key | 349265 |
| Date Received | 2001-08-24 |
| Date of Report | 2001-08-21 |
| Date of Event | 2001-07-16 |
| Date Facility Aware | 2001-08-07 |
| Report Date | 2001-08-21 |
| Date Reported to Mfgr | 2001-08-21 |
| Date Added to Maude | 2001-08-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMPHREY INSTRUMENT |
| Generic Name | ULTRASONIC BIOMETER |
| Product Code | HLN |
| Date Received | 2001-08-24 |
| Model Number | 820 |
| Catalog Number | 820-4152 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 338582 |
| Manufacturer | ZEISIS HUMPHREY SYSTEM |
| Manufacturer Address | 5169 HACIENDA DRIVE DUBLIN CA 94568 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-08-24 |