MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750833

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

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.The manufacturer internal reference number is: 2018-05436.

Event Description

A customer reported that prior to a surgical procedure a staff member tripped over the system power cord removing it from the machine.The system locked.The case was initiated and completed as planned.There was no patient involvement.Additional information was requested and received.

Manufacturer Narrative

Additional information has been provided.The system was examined and the reported event was confirmed.The customer tripped on the power cord, removing it from the machine.The company representative found the touchscreen to be out of calibration, so they recalibrated it, addressing the reported system locking up.A review of the customers complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on march 16, 2006.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported system locking up can be attributed to the touchscreen being out of calibration.The root cause of the reported power cord coming out of the system can be attributed to use error.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7264135
• MDR Text Key: 99919769
• Report Number: 2028159-2018-00274
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Other Device ID Number: 8065750833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other