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

Catalog Number 8065751761

Device Problem Excessive Heating (4030)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

A physician reported that an ophthalmic handpiece heated during phacoemulsification portion while performing the cataract surgery.The surgery was completed on the same day by using the same handpiece.There was no harm to the patient.

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).

Manufacturer Narrative

The phaco handpiece under investigation was confirmed to have exhibited a failure mode related to a nonconforming crystal stack.This event type is consistent with a known issue previously investigated in response to an increased number of system messages and temperature high complaints received from phaco handpieces (hps) with specific manufactured dates.Manufacturing review confirms that this handpiece (hp) was manufactured in alignment with previously investigated handpieces.The root cause is attributed to piezoelectric crystals within the handpiece (hp) having a high dissipation factor, causing fusion and/or shorting.Additionally, excessive application of loctite during handpiece (hp) assembly was identified as a contributing factor.Additional investigation is not necessary for this complaint and will not be performed.¿ the root cause of the reported event can be attributed to the fusing of the crystal stack causing an electrical short circuit between the high and low electrodes.¿ 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: CENTURION 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18499209
• MDR Text Key: 332983361
• Report Number: 2028159-2024-00067
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517619
• UDI-Public: 00380657517619
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1