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

Model Number LXT-JAPAN

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

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 actuation failure of a cutter occurred during surgery.The condition of aspiration is unknown.The surgery was completed after replacing the product with another one.The involved eye and the patient identifier are not available.There was no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector for the report of actuation failure during surgery.The returned sample was visually inspected and found to be non-conforming with the probe needle bent and foreign material on the needle and in the port.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for aspiration and cut and was non-conforming for actuation.The probe was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter was observed to be bent.No wear marks were observed on the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (bent needle and shell assembly) was removed the probe was able to actuate.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination for device component lots traceable to the reported lot number indicates there is one additional complaint associated with the component lots for the reported issue.The complaint evaluation confirms that the probe had an actuation failure.The most likely root cause for the actuation non-conformance is the bent needle and bent inner cutter.A damaged/bent inner cutter can impede the movement of the cutter shaft.This interference is present as observed from visual condition of the inner cutter.After the probe was disassembled (bent needle and shell assembly removed), the probe was able to actuate.The exact root cause of the bent needle and bent inner cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site.An exact root cause for the bent needle and the bent inner cutter was not determined from this evaluation; therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformance's found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9013980
• MDR Text Key: 165116266
• Report Number: 2028159-2019-01660
• 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
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXT-JAPAN
• Device Catalogue Number: 8065752043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1