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

Model Number 800CS

Device Problems Use of Incorrect Control/Treatment Settings (1126); Decrease in Suction (1146)

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

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 experiencing a loss of suction when transitioning from "frag to vit." the tubing was replaced to resolve the issue.Additional information has been requested.

Manufacturer Narrative

The customer called the company representative to schedule servicing.The customer has not been responsive to service call scheduling.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 august 15, 2007.Based on qa assessment, the product met specifications at the time of release.The consumable pack lot number was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Corrected information provided in e.1.Additional information provided in h.10.The customer called the company representative to schedule servicing.The customer has not been responsive to service call scheduling.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 august 15, 2007.Based on qa assessment, the product met specifications at the time of release.The consumable pack lot number was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5910126
• MDR Text Key: 54209362
• Report Number: 2028159-2016-03847
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 800CS
• Device Catalogue Number: 8065741008
• Other Device ID Number: 4.54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2007
• 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
• Treatment: UNSPECIFIED ACCURUS PAK
• Patient Outcome(s): Other