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

Model Number 400VS

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

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

Event Date 06/16/2015

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 reported that during a vtirectomy procedure, the system locked.The case could not be completed.Additional information has been requested.

Manufacturer Narrative

The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.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 june 6, 2001.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The sample received is unrelated to the reported event, therefore is not evaluated.(b)(4).

• Brand Name: ACCURUS SURGICAL 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 ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4916222
• MDR Text Key: 22394173
• Report Number: 2028159-2015-07039
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K911808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 04/11/2016

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 Model Number: 400VS
• Device Catalogue Number: 8065740238
• Other Device ID Number: 4.54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2001
• 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