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

Catalog Number 8065750180

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

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 physician reported finding a hole in the sleeve; the anterior chamber was unstable during ultrasound and leakage of irrigation was also confirmed from the sleeve.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.Only the infusion sleeve was returned for evaluation.Inspection confirmed a hole on the thick base of the sleeve.Microscopic examination identified two sharp edge induced scratches near the hole.The root cause of the customer's complaint could not be conclusively determined with the available information.We could not confirm if this occurred post receipt of the sample but two induced marks near the hole were identified.Action will not be taken for this occurrence.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8912646
• MDR Text Key: 155181497
• Report Number: 2028159-2019-01515
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1