FDA Adverse Event
Injury
Summary report: N
HANSATOME - 115 VOLT UNIT
MDR report key: 376825
·
Received February 8, 2002
Report
- Report Number
- 6000106-2002-00001
- Event Type
- Injury
- Date Received
- February 8, 2002
- Date of Event
- May 18, 2001
- Report Date
- November 13, 2001
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HNO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT HAD AN UNEVENTFUL REFRACTIVE PROCEDURE IN THE RIGHT EYE. PT DEVELOPED DIFFUSE LAMELLAR KERATITIS (DLK) THREE DAYS POST OPERATION. VISUAL ACUITY POST-OP 20/40. FLAP WAS LIFTED AND RINSED TWICE AND FLOATED AND IRRIGATED ONCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HANSATOME - 115 VOLT UNIT | KERATOME-POWERED | HNO | BAUSCH & LOMB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |