FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 3780718
·
Received April 22, 2014
Report
- Report Number
- 2028159-2014-00679
- Event Type
- Injury
- Date Received
- April 22, 2014
- Date of Event
- January 1, 2014
- Report Date
- March 25, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLES WERE RETURNED FOR EVALUATION FOR "TASS". NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT, THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONSIDERED. THE ROOT CAUSE FOR "TASS" CANNOT BE DETERMINED FROM THIS EVALUATION DUE TO NO SAMPLE RETURNED AND NO LOT NUMBER IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A MATERIALS MANAGER REPORTED TWO ADDITIONAL PATIENT'S EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER A PROCEDURE. A REPORIT HAS ALREADY BEEN SENT IN FOR THE OTHER FIVE PATIENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243900 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |