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

Catalog Number 8065750180

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

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: (b)(4).

Event Description

A customer reports that during a procedure the vitrectomy was not working.No complications occurred.Surgeon and staff was instructed by company representative on how to use instruments.Additional information has been requested and received.

Manufacturer Narrative

Additional information has been provided.The system was examined and the reported event was not replicated.However, the company representative suspected that the vitrectomy issues were due to user error, since the footswitch settings were misaligned.As a correction, the company representative advised the surgeon how to use the footswitch and system.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on (b)(6) 2004.Based on qa 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: 7264045
• MDR Text Key: 99996560
• Report Number: 2028159-2018-00271
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750180
• Other Device ID Number: 8065750180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2004
• 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