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

Model Number VRT691027

Device Problem Complete Blockage (1094)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Additional patient information was requested.However, the account stated that this information cannot be provided.Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon experienced some difficulty with the veritas swivel handpiece.The surgeon experienced three clogs, all less than 5 seconds.All cleared spontaneously.There was no patient impact from the clogging.

• Brand Name: VERITAS SWIVEL PHACO HANDPIECE SYSTEM
• Type of Device: 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: 13700745
• MDR Text Key: 296859829
• Report Number: 3012236936-2022-00579
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474700888
• UDI-Public: (01)05050474700888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VRT691027
• Device Catalogue Number: VRT691027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: VERITAS PACK LOT 60314676