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

Model Number LXT

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the probe did not cut during a procedure.Procedure was completed with no patient harm reported.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

Additional information provided in d.10., g.1., g.2., h.3., h.6., and h.10.One opened probe was received with no tip protector, in a bag, for the report of cutting did not work.The returned sample was visually inspected and found to be non-conforming with the inner cutter in the port, the probe needle bent, and foreign material on the port face and inner cutter.The sample was then functionally tested for actuation, aspiration, and cut.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be non-con forming for actuation and aspiration.The sample was unable to be tested for cut functionality due to the observed actuation failure.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.No wear marks were observed on the inner cutter.The cutter was observed to be bent.The inner cutter pulled out of the coupling and the fillet remained adhered to the inner cutter.The appearance of the adhesive left on the inner cutter indicates that the inner cutter was originally bonded to the coupling and the bond was cured.It appears that the entire adhesive bond was pulled from inside of the coupling at some point after the bond was created and cured.Due to the separation of components the conformance of the adhesive bond cannot be determined.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.The complaint sample evaluation indicated that the probe had actuation and aspiration failures.The sample was unable to be tested for cut functionality, however, the observed actuation failure would have caused a cut failure as was reported.The root cause of the observed aspiration failure is the actuation failure, causing the inner cutter to remain in the port and obstruct aspiration flow through the probe.The root cause for the observed actuation failure is due to the separation of components within the probe.It appears that at the beginning of surgical use the adhesive bond failed causing the inner cutter to detach from the coupling.An internal investigation was completed and identified areas to implement additional process controls within the manufacturing process to reduce the frequency of probe complaints for detachments of the inner cutter from the coupling.The procedure was reviewed and found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.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: 9528467
• MDR Text Key: 177845523
• Report Number: 2028159-2019-02326
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK