FDA Adverse Event
Malfunction
Summary report: N
LAUREATE WORLD PHACO SYSTEM
MDR report key: 2193487
·
Received July 13, 2011
Report
- Report Number
- 2028159-2011-00798
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Report Date
- June 13, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT THERE WAS DIFFICULTY PERFORMING PHACO SURGERY IN HARD CATARACTS (BROWN OR BLACK CATARACT), ESPECIALLY IN PTS OVER THE AGE OF 70 YEARS. THEY HAVE EXPERIENCED CLOGGING DURING FRAGMENT REMOVAL, AND WHEN PUSHING THE FOOT PEDAL DEEPER, THE ANTERIOR CHAMBER SURGES AND COLLAPSES. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAUREATE WORLD PHACO SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CTR | LAUREATE | N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |