FDA Adverse Event
Injury
Summary report: N
2023366-1999-00038
MDR report key: 257266
·
Received December 28, 1999
Report
- Report Number
- 2023366-1999-00038
- Event Type
- Injury
- Date Received
- December 28, 1999
- Report Date
- November 9, 1999
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BAUSCH & LOMB SURGICAL RECEIVED NOTIFICATION OF A CORNEAL BURN INCIDENT FROM A EUROPEAN CUSTOMER. THE CUSTOMER WAS USING A CATALYST UNIT; HOWEVER, THE CUSTOMER HAS IDENTIFIED THE FOOTSWITCH AS THE SOURCE OF THE INCIDENT. THE PT REQUIRED AN ADDITIONAL PROCEDURE TO PREVENT FURTHER INJURY.
Description of Event or Problem · 1
BAUSCH & LOMB SURGICAL RECEIVED NOTIFICATION OF A CORNEAL BURN INCIDENT FROM A EUROPEAN CUSTOMER. THE CUSTOMER WAS USING A CATALYST UNIT, HOWEVER, THE CUSTOMER HAD IDENTIFIED THE FOOTSWITCH AS THE SOURCE OF THE INCIDENT. THE PT REQUIRED AN ADDITIONAL PROCEDURE TO PREVENT FURTHER INJURY.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |