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

Model Number TABLETOP

Device Problems Device Displays Incorrect Message (2591); Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

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

A customer reported that during a vitrectomy procedure, a laser system advisory displayed.It was discovered during a company evaluation that the laser power was low and that is why the advisory displayed.The customer reported even though the laser power was low, the procedure could be completed.There was no patient harm.

Manufacturer Narrative

The system was examined and the reported ¿low laser power¿ was replicated.The laser core module was replaced and returned for evaluation, to resolve the issue.The company representative did not indicate finding any issues that would be associated with the reported system message (sm).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 october 10, 2013.Based on qa assessment, the product met specifications at the time of release.A laser core module was received for evaluation.A visual assessment of the returned sample revealed no obvious nonconformity.The laser module was then installed in to a calibrated system for functional testing.Upon testing, the port 2 aiming beam was found to be dim while laser power output was found to meet specifications from both ports.The module was disassembled and a nonconforming diode-aim cable assembly was found.The root cause of the reported low power issue can be attributed to a nonconforming diode-aim cable assembly.However, how or when the diode became nonconforming cannot be determined conclusively.Based on the information obtained the root cause of the reported ¿system message¿ cannot be determined conclusively.The manufacturer internal reference number is (b)(4).

• Brand Name: CONSTELLATION 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6060920
• MDR Text Key: 59013015
• Report Number: 2028159-2016-04826
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 4.00.168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Date Device Manufactured: 10/10/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other