FDA Adverse Event
Injury
Summary report: N
UNIVERSAL II
MDR report key: 3233825
·
Received July 16, 2013
Report
- Report Number
- 2028159-2013-01436
- Event Type
- Injury
- Date Received
- July 16, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 20, 2013
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYED A SYSTEM MESSAGE AND LOCKED PRIOR TO A CATARACT SURGERY. THE PROCEDURE WAS PERFORMED USING A MANUAL TECHNIQUE (ECCE) EXTRACAPSULAR CATARACT EXTRACTION. THERE WAS NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328088 | UNIVERSAL II | PHACOEMULSIFICATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | UNIV II | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |