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

Model Number	VRT691027
Medical Device Problem Codes	Complete Blockage (1094); Failure to Prime (1492); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age or date of birth, weight, and ethnicity: unknown, not provided.Date of event is unknown as it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract procedure, the phaco tip was clogged.A description from the surgery center indicated during the phaco procedure, a 501 and 601 vacuum error displayed and frequent clogs.The procedure was completed, and no patient injury reported.Through follow up, the surgery center has 8 phaco handpieces that were in use at the time of the event.The clogging occurred during the procedure 3 or 4 different times/events, however unable to determine which specific handpiece had the clog during surgery.As a proactive measure, all handpieces will be reported and returned for evaluation.This is 4 of 8 reports.
Additional Manufacturer Narrative
Correction: 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: 5/26/2021.Section h3.Device evaluated by manufacturer? yes.Section h6 coding: type of investigation: 10, 3331.Investigation findings: 180.Investigation conclusions: 4315.The handpiece was received, autoclaved and evaluated.During inspection the silicone aspiration tubing is ruptured at the luer fitting.Ruptured tubing indicates an occlusion may have led to over-pressurization during cleaning.Based on the information a product malfunction and product deficiency was confirmed.Per attached dhr summary page provided all devices meet material, assembly, and performance specifications at the time of product release.Johnson & johnson surgical vision will continue to monitor this type of complaints.

• 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: 11941123
• Report Number: 2020664-2021-07035
• Device Sequence Number: 3856798
• Product Code: HQC
• UDI-Device Identifier: 05050474700888
• UDI-Public: (01)05050474700888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERITAS CONSOLE