FDA Adverse Event
Malfunction
Summary report: N
PUREPOINT
MDR report key: 1891083
·
Received October 22, 2010
Report
- Report Number
- 2028159-2010-02056
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 24, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQF
- PMA / PMN Number
- K062624
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WILL BE SENDING THE SAMPLE FOR IN-HOUSE EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTED THE LASER TIP BROKE OFF IN THE PT'S EYE. THE SURGEON REMOVED IT FROM THE EYE DURING THE INITIAL SURGERY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUREPOINT | LASER, OPHTHALMIC | HQF | ALCON - IRVINE TECHNOLOGY CENTER | PUREPOINT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |