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

Model Number VRT680300

Device Problems Complete Blockage (1094); Pumping Problem (3016)

Patient Problems Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).Section h6 -health effect - clinical code: 4581: shallowing or collapsing of the anterior chamber : anterior chamber collapse.Device evaluation: the field service engineer checked the phaco machine and found nothing wrong.The surgeon's settings were adjusted to suit the new tip size and there have been no further problems.Manufacturing records review: a review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.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.

Event Description

It was reported that there was a problem with the veritas phacoemulsification (phaco) machine.Surgeon reported that there was a problem with the vacuum pump.They had massive occlusion surges which caused anterior chamber (a/c) to collapse and there was no vacuum on the vitrectomy probe afterwards.The patient then had anterior chamber stability issues, a posterior capsule rupture and a vitrectomy was required.Through follow up it was reported that surgeon had started using a different size phaco tip on that day.No further information was provided.A separate report will be submitted for the phaco tip.

Manufacturer Narrative

Corrected information: in the report submitted 9th november 2023 (md-0016791), an incorrect udi was inadvertently submitted.This report contains the corrected udi.Section d4 -(b)(4) all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: VERITAS VISION 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: 18107937
• MDR Text Key: 327878150
• Report Number: 3012236936-2023-02761
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K203060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VRT680300
• Device Catalogue Number: VRT680300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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
• Patient Outcome(s): Other