FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1132627
·
Received August 22, 2008
Report
- Report Number
- 2028159-2008-00298
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR.
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER HAS ONE SAMPLE TO RETURN FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE ANTERIOR VITRECTOMY PROBE FITTING WAS VERY DIFFICULT TO CONNECT WHEN THEY NEEDED TO DO A VITRECTOMY, DUE TO A POSTERIOR CAPSULE TEAR. THEY OPENED 3 PROBES BEFORE THEY COULD "FORCE ONE ONTO THE CONNECTOR". THE CUSTOMER STATED THAT THE POSTERIOR CAPSULE TEAR HAD NOTHING TO DO WITH ANY ALCON CONSUMABLE OR EQUIPMENT. THIS EVENT CAUSED A BRIEF LOSS OF TIME AND FRUSTRATION BUT NO HARM TO THE PT. THE PT IS DOING FINE. THIS WAS THE LAST CASE OF THE DAY OUT OF 18.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CTR. | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |