FDA Adverse Event
Malfunction
Summary report: N
STELLARIS 23G VIT CUTTER 6/BX
MDR report key: 3070446
·
Received April 17, 2013
Report
- Report Number
- 1920664-2013-00088
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 26, 2013
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K101325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN REQUESTED HOWEVER, IT IS NOT AVAILABLE FOR EVAL. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THIS REPORT IS RELATED TO THE EVENT REPORTED ON MDR 1920664-2013-00089 AND 00090.
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(6) STATES: "NO CUTTING ON VITREOUS BODY VISIBLE DURING PROCEDURE. NO PATIENT DAMAGE/NO PATIENT IMPACT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165660 | STELLARIS 23G VIT CUTTER 6/BX | HQC | BAUSCH & LOMB, INC. | U8837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH +LOMB) |