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

Catalog Number 8065752101

Device Problems Break (1069); Leak/Splash (1354)

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

Event Description

A customer reported the ultra sleeve was damaged and irrigating solution leak from it on the outside of the eye during a cataract procedure.The product was replaced and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

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.One 0.9 millimeter (mm) ultra infusion sleeve without bubble suppression insert (bsi) was visually inspected and a pierced hole was found at the center of the infusion sleeve shaft.Irrigation free flow was measured with the 0.9mm mini flared tip and ultrasonic handpiece and met specifications.During testing, fluid leakage was visually detectable originating from the pierced hole on the shaft.The damage was not made by a sharp edge rather exhibited signs of a puncture and tear.The tear is consistent with damage that occurs as a result of the phaco tip inadvertently piercing through the infusion sleeve during attaching to the handpiece.This error will cause a tear in the infusion sleeve.The customer should be reminded the directions-for-use state good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering based on the analysis of the returned sample, the customer's event is related to customer handling during the surgical set up process.Improper mounting of the infusion sleeve on the handpiece phaco tip can cause a tear or piercing through the infusion sleeve, leading to the customer's reported experience.After an investigation of this complaint, it has been determined that no action will be taken at this time as the root cause is related to user handling.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 9665148
• MDR Text Key: 183094582
• Report Number: 1644019-2020-00069
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 8065752101
• Device Lot Number: 2273121H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI VISION SYSTEM