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

Model Number LXT

Device Problem Mechanics Altered (2984)

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 there was an actuation failure of a vitrectomy probe during a procedure.The condition of aspiration was unknown.The procedure was completed after replacing the product with another one.There was no harm to the patient.

Manufacturer Narrative

One opened probe was received with no tip protector, in a tray, for the report of actuation failure.At the time of sample receipt it was noticed that the probe needle was bent at the stiffener sleeve.The returned sample was visually inspected and found to be non-conforming.The probe needle is bent approximately ninety degrees at the stiffener, the inner cutter is in the port, and orange/brown foreign material was observed to be covering approximately half of the port.The sample was then functionally tested for actuation, aspiration and cut and was found to be non-conforming for all three functional tests.The probe was disassembled and the components inspected.The degree of wear could not be determined and a visual of the inner cutter could not be performed since the inner cutter broke off in the needle while trying to extract it.After functional testing was performed and most of the foreign material came off of the port it was observed that the port was deformed.Although the inner cutter could not be removed for a wear evaluation, a review of the portion of the inner cutter that is in the port shows wear that indicates the probe was used for a time greater than what would be seen during the testing performed as part of the manufacturing process of this product.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 are two additional complaints associated with the component lots for the reported issue.The complaint evaluation confirms that the probe had an actuation failure and also indicated that the probe had a cut failure.Unrelated to the reported event, the evaluation indicated that the probe had an aspiration failure.The most likely root cause for the observed non-conformance's 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.The exact root cause of the deformed port and the observed foreign material cannot be determined from this evaluation.The wear that could be observed on the inner cutter indicated that the returned probe was used for a time greater than what would be seen during the testing performed as a prat of manufacturing, therefore, the most likely root cause of the deformed port and the foreign material is handling at any point after the product was shipped from the manufacturing site, including use during surgery.An exact root cause for the bent needle, bent inner cutter, deformed port, and foreign material 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.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: 9069809
• MDR Text Key: 164590069
• Report Number: 2028159-2019-01667
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• 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: 8065751550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK