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

Model Number LXT-JAPAN

Device Problems Failure to Deliver Energy (1211); Dull, Blunt (2407)

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.A product sample has been shipped; however, it has not been received for evaluation at the manufacturing site.(b)(4).

Event Description

A doctor reported that the actuation of probe failed and cutter movement was dull during a procedure.The aspiration function is unknown.The product was replaced and procedure complete with no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray with other items, for the report of actuation failure of probe and dull movement of cutter.The returned sample was visually inspected and found non-conforming with foreign material in the inner diameter of the port.The sample was then functionally tested for actuation, aspiration and cut.The sample was found conforming for actuation and was non-conforming for aspiration and cut.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.Gouge marks were observed at the bend area and one other location along the inner cutter.The sample was tested with a syringe and resistance was felt.A wire enters the aspiration path but does not go all the way through.Solid material is blocking the aspiration path and cannot be removed for further evaluation.A review of the device history records 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 indicates there are three additional complaints associated with the lot for the reported issue.The complaint evaluation did not confirm that the probe had an actuation issue.The evaluation did confirm that the probe had a cut issue.Unrelated to the reported event, the evaluation also indicated that the probe had an aspiration issue.The most likely root cause for the poor cutting is the observed damage to the inner cutter of the probe.A damaged inner cutter can impede the movement of the cutter shaft, causing to probe to not be able to perform the cut.How and when the inner cutter of the probe became damaged cannot be determined form this evaluation.The most likely root cause for the aspiration issue is the foreign material in the port and in the aspiration path.How and when foreign material was introduced cannot be determined from this evaluation no specific action with regard to this complaint was taken by the manufacturing site because the exact root cause for the cut issue cannot be determined from this evaluation.All probes are 100% 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: 8414166
• MDR Text Key: 138780042
• Report Number: 2028159-2019-00395
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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: LXT-JAPAN
• Device Catalogue Number: 8065752043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK