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

Catalog Number 8065750469

Device Problem Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

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 customer reported that the phacoemulsification handpiece does not vibrate.Procedure details and patient impact have not been provided.Additional information has been requested and received.The customer indicated the handpiece did not vibrate during the sculpt phase of a cataract extraction procedure.The handpiece was exchanged and the surgery was completed with no impact to the patient.

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10879598
• MDR Text Key: 218510256
• Report Number: 2028159-2020-00996
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K112425
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI VISION SYSTEM OZIL