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

Model Number VRT680300

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

Age at time of event: unknown/ not provided.Date of birth and gender: unknown/ not provided.Patient weight: unknown/ not provided.Ethnicity and race: unknown/ not provided.Device evaluation: a review of the device history record (dhr) showed that the system and its components met all specifications prior to being released.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that while performing anterior vitrectomy on a patient, due to capsular tear during phaco, surgeon said that cut rate at 2500 tended to choke out, he lowered to 1500 and said worked fine.He completed the case to include intraocular lens implant in the capsular bag without further incident.No further information provided.

• 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: 13578878
• MDR Text Key: 290043519
• Report Number: 3012236936-2022-00468
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/27/2022
• Date Device Manufactured: 11/03/2021
• 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