MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER HAND PIECE

Catalog Number ASKU

Device Problem Disconnection (1171)

Patient Problems Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/26/2021

Event Type  Injury  

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 health professional reported that during a routine cataract extraction procedure the irrigation tubing disconnected from the phacoemulsification handpiece.The patient¿s eye pressure was affected.The surgeon stopped the procedure and realized that the handpiece had caused damage which required an additional vitrectomy procedure.The tubing was tested prior to the surgery and determined to be secure.The procedure was completed after a delay.Additional information was requested but not yet received.

Manufacturer Narrative

The handpiece was not returned for evaluation.The serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer 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: HAND PIECE
• Type of Device: UNK
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11995594
• MDR Text Key: 256162620
• Report Number: 2028159-2021-00634
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention