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

Model Number JAPAN

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

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.(b)(4).

Event Description

A surgeon reported that the system froze before a procedure.An alternate system was used to initiate and complete the surgery.There was no patient impact reported.Additional information is not expected for this report.

Manufacturer Narrative

Additional information has been provided.The company service representative examined the system and was unable to replicate the reported event.As a preventive measure, the company service representative reseated the connections within the host module.The system was then tested and met all product specifications.The system was manufactured on december 12, 2007.Based on quality assurance assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.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: 7621634
• MDR Text Key: 112071669
• Report Number: 2028159-2018-01285
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JAPAN
• Device Catalogue Number: 8065751143
• Other Device ID Number: 380657511433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2007
• 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