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

Catalog Number ASKU

Device Problem Temperature Problem (3022)

Patient Problem Corneal Edema (1791)

Event Date 11/01/2020

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 surgeon reported the phacoemulsification handpiece got warm during a surgical procedure and the patient experienced corneal edema that lasted weeks after surgery.Additional information has been requested but has not been received.This is one of two reports from this facility.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.The handpiece was not returned for evaluation.With no additional, related information provided, the customer reported events were not able to be confirmed.Based on the information obtained, the root cause of the reported events cannot be determined conclusively.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: 10944387
• MDR Text Key: 219491068
• Report Number: 2028159-2020-01043
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other