FDA Adverse Event
Injury
Summary report: N
LAZER EDGE OPHTHALMIC KNIFE
MDR report key: 6025761
·
Received October 13, 2016
Report
- Report Number
- 0001920664-2016-00383
- Event Type
- Injury
- Date Received
- October 13, 2016
- Date of Event
- January 14, 2016
- Report Date
- September 20, 2016
- Manufacturer
- BAUSCH + LOMB
- Product Code
- HNN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
DURING CATARACT SURGERY OF THE RIGHT EYE THE KNIFE WAS NOT CUTTING. STRONGER FORCE THAN USUAL HAD TO BE APPLIED AND THE KNIFE SLIPPED AND ERODED THE CORNEA ON ABOUT 2 X 10 MM. THE KNIFE HAD TO BE CHANGED TO COMPLETE THE SURGERY. SINCE THE SURGERY THE PATIENT HAS PRESENTED RECURRENT TRAUMATIC KERATALGIA AND STRONG TUMEFACTION OF THE EYE LEADING TO SEVERAL CONSULTATIONS. THE PATIENT HAS NOT RECOVERED AND WILL BE SEEN BY A CORNEAL SPECIALIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679762 | LAZER EDGE OPHTHALMIC KNIFE | 2.0-2.2MM ANGLED TRAPEZOIDAL KNIFE | HNN | BAUSCH + LOMB | E7601 | MAPC520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |