FDA Adverse Event
Malfunction
Summary report: N
ILLUMINATED FLEX CURVED LASER PROBE, 23GA
MDR report key: 3880962
·
Received April 7, 2014
Report
- Report Number
- 2028159-2014-00612
- Event Type
- Malfunction
- Date Received
- April 7, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 11, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQF
- PMA / PMN Number
- K062624
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED A PROBE FAILED, AND NOTICED SMOKE DURING A PROCEDURE. THE CASE WAS COMPLETE BY EXCHANGING THE PRODUCT. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 207065 | ILLUMINATED FLEX CURVED LASER PROBE, 23GA | LASER, OPHTHALMIC | HQF | ALCON - IRVINE TECHNOLOGY CENTER | 8065751592 | 13034885X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |