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

Model Number VRT680300

Device Problems Computer Software Problem (1112); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2022

Event Type  Injury  

Event Description

It was reported that the surgeon switched to dense mode and once it switched they heard a noise and a 374 error (handpiece removed after being tuned) popped on system.They had to retune the handpiece during surgery.Soon after the surgeon had to do a vitrectomy.No additional information was provided.This report is for the veritas console.Refer to 3012236936-2022-02700 for the handpiece.

Manufacturer Narrative

(b)(4).Device evaluation: field service engineer (fse) visited site and confirmed error in log however, was unable to observe the issue during testing.Verified phaco mode function and calibration.Performed annual preventative maintenance (pm) while onsite.System meets jnj vision specs.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.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.

• 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: 15686629
• MDR Text Key: 302567740
• Report Number: 3012236936-2022-02699
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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: HANDPIECE SN (B)(4)
• Patient Outcome(s): Required Intervention