MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-10-28 for ULTRASONIC BIOMETER 820 NA manufactured by Carl Zeiss Meditec Inc.
[17429641]
The incident involved the ultrasonic biometer. This was giving the wrong calculation resulting in 8 incorrect surgeries. The eight pts are ending up with farsighted results with an error of 2. 0 diopters. It has been reported, after examining the pts' exam printout, that the doctor noticed the a-constant did not match the lens they were using before, which was causing the miscalculation. At the time the incident was reported, the user facility stated that the instrument now has the correct a-constant, and is operating within specifications. Doctor claimed that manufacturer's service rep entered the a-constant during the last service call but only the doctor would known the correct a-constant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2002-00002 |
| MDR Report Key | 424973 |
| Report Source | 05 |
| Date Received | 2002-10-28 |
| Date of Report | 2002-10-28 |
| Date of Event | 2002-07-12 |
| Date Mfgr Received | 2002-09-26 |
| Device Manufacturer Date | 1987-12-01 |
| Date Added to Maude | 2002-11-01 |
| 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 |
| Manufacturer Street | 5160 HACIENDA DR. |
| 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 | ULTRASONIC BIOMETER |
| Generic Name | LENS MEASURING INSTRUMENT |
| Product Code | HJB |
| Date Received | 2002-10-28 |
| Model Number | 820 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 414027 |
| Manufacturer | CARL ZEISS MEDITEC INC |
| Manufacturer Address | 5160 HACIENDA DR. DUBLIN CA 94568 US |
| Baseline Brand Name | * |
| Baseline Generic Name | * |
| Baseline Model No | 820 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-28 |