MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER SERIES 20000 LEGACY SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number STTL

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

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 nurse reported to a company representative that the tip sleeves they received were difficult to insert through the incision, maneuver within the anterior chamber, and broke easily during a cataract procedure.The tip sleeves were replaced and the procedure was completed.There was no indication of patient harm.Additional information was requested; however, none has been received to date.This is one report of two for this facility.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.A sample was not returned for this complaint report; visual inspection or functional testing could not be conducted in order to establish a potential failure mode for the device.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.The manufacturer internal reference number is: (b)(4).

• Brand Name: SERIES 20000 LEGACY SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8436388
• MDR Text Key: 139534044
• Report Number: 2028159-2019-00478
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K952213
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STTL
• Device Catalogue Number: 8065750131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEGACY SURGICAL PROCEDURE PAK