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

Model Number TABLETOP-JAPAN

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

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 the probe actuation did not work during a procedure.The product was replaced and procedure completed with no patient harm.

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 a tip protector, in a bubble bag along with other items, for the report of actuation failure.The returned sample was visually inspected and found to be non-conforming with the needle bent at the stiffener and orange/brown foreign material on the port face.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be non-conforming for actuation and aspiration.The cut functionality of the probe was unable to be tested due to the 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.The inner cutter pulled out of the coupling.Presence of adhesive was observed at one place on the inner cutter.The cutter/coupling adhesive bond fillet was visually inspected and found to be non-conforming.The inner cutter was observed to be bent.No wear marks were observed on the inner cutter.Orange/brown foreign material was observed to be clogging the inner diameter of the cutter.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 evaluation confirmed that the returned probe had an actuation failure, and also indicated that the probe had an aspiration failure.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.The root cause for the aspiration non-conformance is due to foreign material in the aspiration path.How and when foreign material was introduced into the aspiration path cannot be determined from this evaluation; however, the visual attributes of the foreign material indicate that the material is most likely surgical material from the surgical use of the probe.An investigation has been completed and actions have been implemented to lower the frequency of probe complaints due to the detachment of the inner cutter from the coupling.The procedure has been reviewed and was found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.The inner cutter / coupling adhesive bond fillet for the returned sample was non-conforming.Therefore, an investigation photo of the returned sample has been issued within the learning management system for review with the applicable production personnel to raise awareness of this issue.The exact root cause of the foreign material in the aspiration pathway could not be determined from the evaluation performed, therefore, no additional action was taken by the manufacturing site.Probe assemblies 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 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: 9476156
• MDR Text Key: 176825071
• Report Number: 2028159-2019-02261
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.