FDA Adverse Event
Malfunction
Summary report: N
STORZ COMPUSCAN LT
MDR report key: 43149
·
Received October 3, 1996
Report
- Report Number
- 1920664-1996-00688
- 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 |