MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. VERITAS SWIVEL PHACO HANDPIECE SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	VRT691027
Medical Device Problem Codes	Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h3-other (81): the phaco handpiece was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that their handpiece was hot in the physician's hand and phaco sounded funny.Initial tune and prime were fine.No patient injury reported.No further information provided.
Additional Manufacturer Narrative
Correction: section h4: in initial report, the manufacturer date provided was inadvertently reported as 04/23/2021, however the correct date is 02/24/2021.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on dec 4, 2024.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection was performed, and a phaco handpiece was received within original packaging confirming the reported serial number.The product did not reveal any obvious defects and damage.The handpiece was connected to a veritas console using a known good opo73 pack and priming was commenced.Prime was completed successfully without errors.The body of the handpiece was not warm to the touch and no unusual noises were observed.The reported event could not be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: VERITAS SWIVEL PHACO HANDPIECE SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18378794
• Report Number: 3012236936-2023-03231
• Device Sequence Number: 15395357
• Product Code: HQC
• UDI-Device Identifier: 05050474700888
• UDI-Public: (01)05050474700888
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K203060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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
• Operator of Device: Health Professional
• Device Model Number: VRT691027
• Device Catalogue Number: VRT691027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown