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

Model Number TABLETOP-JAPAN

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that cutting of the cutter was poor during a procedure; the tube felt strange from the beginning and was the assumed cause.The condition of aspiration is unknown.The procedure was completed without product replacement.There was no patient harm.

Manufacturer Narrative

(b)(4).The returned sample was visually inspected and found to be non-conforming with the probe needle bent and cracked at the stiffener sleeve 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 conforming for aspiration and was non-conforming for actuation and cut.The probe was disassembled and the components inspected.The inner cutter broke off in the needle while trying to extract it, therefore, a wear evaluation and overall evaluation of the inner cutter was unable to be performed.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 confirms that the probe had a cut failure, and also indicated that the probe had an actuation failure.The most likely root cause for the actuation and cut non-conformance is from the bent/cracked needle and inner cutter.A damaged/bent inner cutter can impede the movement of the cutter shaft.The exact root cause of the bent/cracked needle and 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 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-conformances 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: 9135083
• MDR Text Key: 172013215
• Report Number: 2028159-2019-01773
• 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: 12/19/2019

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: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK