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

Catalog Number 8065750833

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

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

A customer reported that a system froze up before a procedure.There was no patient involved.

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).

Manufacturer Narrative

The customer reported that the system froze and would not respond to the touch screen, remote control, or standby switch prior to a procedure.The company representative examined the system and replaced a host module to address the reported problem.The system was then tested and met all product specifications.A host module was received and a visual assessment of the returned host module did not reveal any non-conformity.The returned host module was installed onto a calibrated system.The system was turned on via the standby switch and allowed to boot.The system turned on and successfully booted.Various system modes and parameters were manually activated via the touch screen.The system modes and parameters responded normally when activated and no system froze occurred.Various system modes and parameters were activated via the remote control.The system modes and parameters responded normally when activated and no system froze occurred.The system was shut down via the standby switch.The system responded to the standby switch action and shut down normally.Testing was performed approximately 30 minutes.The returned host module functioned normally and no system freeze occurred during testing.The system was manufactured on january 31, 2007.Based on qa assessment, the product met specifications at the time of release.The returned host module functioned properly; therefore, the root cause of the reported events cannot be established.(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: eddie darton, md, jd ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4772777
• MDR Text Key: 17999225
• Report Number: 2028159-2015-06023
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2015

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: 8065750833
• Other Device ID Number: 2.06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2007
• 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