MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 690880

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

Unknown/ not provided.(b)(4).Manufacturing records review: a manufacturer record review related to the device including device history record will be performed.Upon completion of this review, if there is any further relevant information obtained that changes the facts and/or conclusion, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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 handpiece.Refer to 3012236936-2022-02699 for the veritas console.

Manufacturer Narrative

Correction: section h4: in the initial report the initial report the manufacturer date provided for the handpiece was inadvertently reported as 10/27/2021, however the correct date is 07/27/2021.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• 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: 15686666
• MDR Text Key: 302567532
• Report Number: 3012236936-2022-02700
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981116
• 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,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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: VERITAS CONSOLE SN (B)(6)
• Patient Outcome(s): Required Intervention