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

Model Number LXT

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and it is awaiting evaluation.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 laser did not function (laser emitting failure) during surgery.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

No further system information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The returned used pack was visually inspected; the drip chamber and the probe were cut off from their respective manifolds.The endoilluminator was not returned.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The led rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.Replacing the administration and the probe manifolds, the sample was tested.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the irrigation bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.The cleaning process was able to be performed after functional test had completed.The device history record (dhr) shows the product was released per specifications.The cassette successfully primed.The 25 gauge laser probe was received and a visual assessment of the returned sample showed that the laser probe handpiece was cut off and not returned.Therefore, functional testing could not be performed.The 25 gauge laser probe was manufactured on august 22, 2017.There were 2016 paks associated with this lot.Based on 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).

• 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
• MDR Report Key: 7623361
• MDR Text Key: 112071578
• Report Number: 2028159-2018-01289
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXT
• Device Catalogue Number: 8065751145
• Other Device ID Number: 380657511457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; UNSPECIFIED LASER PROBE
• Patient Outcome(s): Other