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

Catalog Number 8065750121

Device Problem Overheating of Device (1437)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

A physician reported that ophthalmic handpiece has three hot spots at the same latitude on the tail were found.The handpiece heat was increases from the inside out, and then the temperature is concentrated in three positions of the handpiece, resulting in hot spots no report of any patient harm.No patient harm was reported.

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

A non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The sample has not been received by the irvine technology center (itc); therefore, the sample was not tested.Based on the information obtained, the root cause of the reported event is inconclusive.The root cause of the reported event is inconclusive.Therefore, no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided in sections d.9, h.3, h.6 and h.10.The handpiece was received at the manufacturing site.A visual assessment of the returned sample revealed did not reveal any nonconformity on the shell after the handpiece was autoclaved.When the handpiece was connected to a calibrated breakout test box, the resistance and dissipation between low electrode and high electrode were both within specifications.The returned sample was connected to a calibrated centurion vision system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the handpiece was measured per the product design specification and was found to be out of specifications.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the torsional stroke measurement of the handpiece did not meet specifications per manufacturing test procedure (mtp).Disassembling the handpiece did not reveal any nonconformities.Refer to the attached investigation log and dynamic test fixture (dtf) report.The reported event was confirmed through testing at manufacturing site which found the shell temperature of the handpiece to be out of specification.Unrelated to the reported event, the stroke length testing also did not meet specifications.Upon disassembly, no nonconformities were observed.How or when the issues arose remains inconclusive.The manufacturer internal reference number is: 2023-23611.

• Brand Name: INFINITI VISION SYSTEM, ACCESSORY, ULTRASOUND 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: 16831563
• MDR Text Key: 314171917
• Report Number: 2028159-2023-00607
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657501212
• UDI-Public: 00380657501212
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

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: 8065750121
• Device Lot Number: 149HNR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 06/19/2023; 08/17/2023
• Supplement Dates FDA Received: 07/12/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1