FDA Adverse Event
Injury
Summary report: N
LASER EDGE OPHTHALMIC KNIFE
MDR report key: 6079025
·
Received November 4, 2016
Report
- Report Number
- 0001920664-2016-00416
- Event Type
- Injury
- Date Received
- November 4, 2016
- Date of Event
- October 6, 2016
- Report Date
- October 7, 2016
- Manufacturer
- BAUSCH + LOMB
- Product Code
- HNN
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EVALUATION RESULTS ARE STILL PENDING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(4) STATING THAT THE KNIFE WAS DULL AND PRODUCED IRRITATION IN THE EYE. A MARK ALSO APPEARED WHERE THE KNIFE WAS USED. DURING THE SURGERY THE MARK DISAPPEARED A LITTLE. AT THE MOMENT, THE PATIENT DOESN'T FEEL ANY DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 730066 | LASER EDGE OPHTHALMIC KNIFE | 20 GAUGE MVR BLADES 6/BOX | HNN | BAUSCH + LOMB | E7520 | MAKC810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |