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

Model Number	690880
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012236936-2022-02700
• Device Sequence Number: 12587869
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERITAS CONSOLE SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown