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

Model Number VRT680300

Device Problems Computer Software Problem (1112); Suction Problem (2170); Pumping Problem (3016); Noise, Audible (3273)

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

Event Date 12/12/2023

Event Type  Injury  

Event Description

It was reported that during irrigation and aspiration (ia) after phacoemulsification, at the start of surgery, there was a loud noise around the pump causing a system error (134).The physician tried removing and replacing the pack, but the situation did not change.Since it was in the middle of ia, rough cortex was removed using a bi-manual ia with a shimko needle.After that, the continuation of the surgery was abandoned, and a large amount of ointment was used in the patients eye, and closed with an eye patch.The physician classed this as a second surgical intervention.Over two hours later a replacement machine was brought and the procedure was to be continued.However, due to the effect of the ointment applied in the patient's eye, the physician's visibility of the eye was severely reduced during the procedure and it was extremely difficult to finish the surgery as the patient's eyelashes were difficult to maneuver.It was also difficult to put a bandage on the patients eye properly.The physician is concerned this may lead to an infection in the patients eye.The doctor also stated feeling the aspiration being weak recently.There was a 180 minute significant delay.Procedure was successfully completed with backup eventually.This procedure was the fourth surgery of the day.No further details provided.

Manufacturer Narrative

Section a2 and a4: unknown, as information was requested but not provided.Section d6a - implant date: not applicable, as there is no indication that the lens was implanted.Section d6b - explant date: not applicable, as there is no indication that the lens was implanted.Section e1 - email address: unknown, as information was requested but not provided section e1 - telephone number: (b)(6).Section h3 - other (81): the device was not returned for evaluation.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.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: additional information was received and it was learned that the patient has no injuries.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the field service engineer evaluated the device and believes that the drain pump roller pin dropped down causing the issues.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9 - device available for evaluation? yes.Section h3 - device evaluated by manufacturer? yes.Device evaluation: service onsite by the field service engineer to evaluate the system.Service found one of the drain pump roller pins had fallen off.The pin got caught in the groove and drain pump stopped.The drain pump was replaced.After that, error 134 occurred.Probable cause: component failure [drain pump].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: 18414690
• MDR Text Key: 331581773
• Report Number: 3012236936-2023-03266
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474700864
• UDI-Public: (01)05050474700864
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian