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

Model Number VRT680300

Device Problem Computer Software Problem (1112)

Patient Problems Eye Pain (4467); Swelling/ Edema (4577)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).Section h3 - other (81): the veritas system has not been evaluated.Therefore, a failure analysis of the complaint device could not be completed.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.All pertinent information available to johnson & johnson surgical vision has been submitted.H3 other text : see h10.

Event Description

It was reported that during the "divide & conquer" phase of the surgery, there was a phaco system failure, leading to multiple error messages and technical issues.This forced the surgeon to temporarily stop the procedure and wait for a second machine to be delivered.The surgeon was forced to close the patients eyes.This situation posed a risk of acute glaucoma and inflammations.Once the new veritas machine was available, the procedure resumed.However, the patient's eye showed signs of edema and experienced intense pain despite receiving analgesics.Furthermore, the patient's blood pressure was significantly elevated, making the surgery complicated following interruption of procedure 5 hours earlier.No further details were provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section h3: device evaluated by manufacturer: yes.Device evaluation: a product evaluation was conducted in response to the incident, and it was determined that the malfunction was triggered by alarms (errors 501, 502, and 503), leading to the replacement of some parts.The probable cause of the incident was identified as a component failure involving the sig pro solenoid/str gauge assy and ssc assy.During a service assessment to check this system, a service deficiency was not identified.Additionally a design deficiency or user/usage deficiency were not identified.The system was checked and is working within johnson & johnson surgical vision (jjsv) specifications.Manufacturing records review: there were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 17075525
• MDR Text Key: 316661355
• Report Number: 3012236936-2023-01305
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 10/16/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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
• Patient Outcome(s): Required Intervention