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

Model Number	VRT691027
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity not provided.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, 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 handpiece got clogged during surgery.Case was finished fine with ellips fx handpiece.
Additional Manufacturer Narrative
Additional information: it was reported by the jnj account sales manager that the customer uses a quick rinse system to blow high pressure air thru the hand pieces.Correction: it was initially reported that the case was completed by using an ellips handpiece however, jnj was able to review video that relates to the event.The video shows that the veritas handpiece was not removed from the eye.H4 - manufacturing date - the manufacturing site reported that the manufacturing date for the device is february 24, 2021.Section d9 device available for evaluation? yes returned to manufacturer: yes returned to manufacturer date: august 31, 2021 section h3.Device evaluated by manufacturer? yes section h6 coding: type of investigation: 10, 3331, 4109, 4110.Investigation findings: 114.Investigation conclusions: 4315.Device evaluation: since handpiece was not exchange this means that minimal troubleshooting was performed and so it is not possible to confirm that these were actually handpiece clogs.Microscope examination found no debris visible in the horn or lure borescope inspection found the aspiration line to be dirty but with no significantly sized particles.Gap area looked same.In the tubing region, the tube was found to be ruptured or torn off the lure fitting ¿ note this was not reported previously.This rupture could possibly happen after the experienced clog when user tried to flush out the clog during decontamination process.However, based on information obtained, the reported event of clog could not be confirmed, and the root cause of rupture could not be determined.Device history record was reviewed and all devices meet material, assembly, and performance specifications at the time of product release.

• Brand Name: VERITAS SWIVEL PHACO HANDPIECE SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12236656
• Report Number: 2020664-2021-07072
• Device Sequence Number: 17027229
• Product Code: HQC
• UDI-Device Identifier: 05050474700888
• UDI-Public: (01)05050474700888
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1