MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON LEGACY SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065750517

Device Problems Break (1069); Material Discolored (1170); Infusion or Flow Problem (2964); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 healthcare professional reported the sleeves were not the same as they had different shades of color, the lighter ones were thinner, broke more easily when they were being placed in the phacoemulsification (phaco) needles, get curled especially when trying to enter the incision, and there was a significant reduction in infusion into the eyes.There was no patient harms reported.This is one of multiple reports for these reported events.

Manufacturer Narrative

The customer did not retain the product lot information.Therefore, the device history records traceable to the reported procedure pack could not be reviewed.It was reported by the customer, that there was variation in the infusion sleeve coloration.Although, no sample has yet been received.Review of a customer provided image, appears to show color variation between infusion sleeves.However, without analysis of the samples, we cannot conclusively determine, there is a non-conformance.The color criteria for this sleeve is evaluated, during inspection, and the color was determined, to be within the allowable acceptance criteria for this sleeve.The color variation should not impact the intended function of the sleeve.The product was not returned.And therefore, a root cause evaluation could not be performed.The root cause of the customer's complaint could not be determined conclusively, as the samples were unable to be evaluated.However, the source of the color variation would originate from the supplier's manufacturing process.This complaint has been reviewed.And the supplier has been made aware of this complaint issue.The supplier has been reviewing their process to ensure greater consistency in sleeve coloration.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGACY SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12843810
• MDR Text Key: 281011913
• Report Number: 1644019-2021-00738
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657505173
• UDI-Public: 00380657505173
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750517
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION PROCEDURE PAK; CENTURION SURGICAL PROCEDURE PAK