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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.(b)(4): 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
During a cataract procedure, the phaco veritas swivel handpiece became clogged during surgery.A description from the surgery center indicated there was clogging in the handpiece using the settings for venturi vacuum at 375mmhg and a 19-gauge tip.The clog was cleared by removing handpiece out of eye and immersing tip in balance salt solution (bss), building to max vacuum and phaco power, pinching aspiration line and then releasing.The procedure was completed, and no patient injury reported.It was reported the handpiece will not return for evaluation and the tubing pack was discarded.

• 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: 11975059
• Report Number: 2020664-2021-07044
• Device Sequence Number: 11663779
• Product Code: HQC
• UDI-Device Identifier: 05050474700888
• UDI-Public: (01)05050474700888(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/10/2021
• 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, TIP,VRT-AI TUBING PACK