FDA Adverse Event
Malfunction
Summary report: N
STORZ COMPUSCAN LT
MDR report key: 43154
·
Received October 3, 1996
Report
- Report Number
- 1920664-1996-00689
- Event Type
- Malfunction
- Date Received
- October 3, 1996
- Date of Event
- August 20, 1996
- Report Date
- September 4, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HJB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USER WILL RECEIVE AN ADDITIONAL TRAINING.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ COMPUSCAN LT | OPHTHALMIC A-SCAN | HJB | STORZ INSTRUMENT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |