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

Catalog Number 8065750180

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Loss of Power (1475)

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

Event Date 10/04/2017

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

An ophthalmic surgeon reported that the system crashed between two surgeries after moving the system from one room to another room.The staff was unable to restart the system in the second room.Technical services was called and it was recommended to do a hard shut down.This was performed and the system could be restarted.Surgeries were canceled due to this event.Additional information has been requested and received.

Manufacturer Narrative

Correction: supplemental medical device report (smdr) # 01 is being filed to correct the date received by manufacturer date on the initial report, filed earlier.Incorrect date of 10/9/2017 is being corrected to 10/05/2017.(b)(4).

Event Description

Additional information was received.The system was not moved from one room to another as previously reported.After positioning the patient the system was rotated a quarter of a circle at which time the system froze.Switching the system off and on twice did not resolve the issue.There was no patient involvement.

Manufacturer Narrative

The customer reported that the system shut down.The power from the battery was disconnected in order for the system to be rebooted.There was no patient harm.The company service representative examined the system and was unable to confirm or replicate the reported event.As a preventive measure, the company service representative replaced the host and power cord.The system was then tested and met all product specifications.The system was manufactured on november 24, 2003.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined the manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The sample was received.However, the sample will not be tested as it was replaced as a preventive measure.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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7080257
• MDR Text Key: 93878821
• Report Number: 2028159-2017-04469
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2018

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: 2.06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 12/04/2017; 12/22/2017; 02/27/2018
• Supplement Dates FDA Received: 12/14/2017; 01/19/2018; 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2003
• 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
• Patient Age: 85 YR