MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-03 for STORZ COMPUSCAN LT ULT1000 manufactured by Storz Instrument Co..
[29650]
Pt was implanted with a lens that had been calculated using this ophthalmic a-scan. Post operative eval of the pt found the vision to be 3-5 to 4. 0 diopters off. Pt's vision is correctable with glasses. No lens exchange is planned at this time.
Patient Sequence No: 1, Text Type: D, B5
[7770446]
The user will receive an additional training.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-1996-00688 |
| MDR Report Key | 43149 |
| Report Source | 05,06 |
| Date Received | 1996-10-03 |
| Date of Report | 1996-09-04 |
| Date of Event | 1996-08-20 |
| Date Facility Aware | 1996-08-20 |
| Report Date | 1996-09-04 |
| Date Mfgr Received | 1996-09-04 |
| Device Manufacturer Date | 1993-12-01 |
| Date Added to Maude | 1996-10-21 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ COMPUSCAN LT |
| Generic Name | OPHTHALMIC A-SCAN |
| Product Code | HJB |
| Date Received | 1996-10-03 |
| Model Number | NA |
| Catalog Number | ULT1000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 30 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 44119 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 3365 TREE COURT IND BLVD ST LOUIS MO 63122 US |
| Baseline Brand Name | STORZ COMPUSCAN DIAGNOSTIC ULTRASOUND |
| Baseline Generic Name | ULTRASONIC PULSED ECHO IMAGING SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | ULT1000 |
| Baseline ID | * |
| Baseline Device Family | DIAGNOSTIC ULTRASOUND |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K903278 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-03 |