FDA Adverse Event
Malfunction
Summary report: N
SERIES 20000 LEGACY
MDR report key: 2241412
·
Received August 18, 2011
Report
- Report Number
- 2028159-2011-00956
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- July 9, 2011
- Report Date
- July 19, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION REGARDING PRODUCT EVALUATION IS PENDING. 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 SURGEON REPORTED THAT DURING PHACOEMULSIFICATION, THE EQUIPMENT DISPLAYED A FROZEN SCREEN. THERE WAS A 20 MINUTE DELAY AND THEN THE SURGERY WAS CONVERTED TO AN EXTRACAPSULAR CATARACT EXTRACTION. THE SURGERY WAS COMPLETED AND THE SURGEON REPORTS THAT THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES 20000 LEGACY | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |