MAUDE Adverse Event Report: Johnson & Johnson Surgical Vision, Inc. ELLIPS FX PHACO HANDPIECE; Unit, Phacofragmentation

Model Number	690880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4, a5, and a6: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the device is not an implantable device.Section d6b: if explanted, give date: not applicable, as the device is not an implantable device.Section e1.Telephone number, (b)(4) section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
The customer reported a possible incision burn caused by the phaco.The physician expressed surprise and noted that he had not encountered this issue since his school years.No patient impact or additional device details were provided.Additional information was received, stating that the surgery date was that the medical doctor did not notice anything different during his phaco but noticed a "burn" at the main incision.It was also reported that unplanned medical or surgical intervention occurred, with 2x sutures needed, and the sutures were required for a leaky incision due to burn.Note: this is report 1 of 4.

• 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 ; +1(714)247-8552
• MDR Report Key: 50734766
• Report Number: 3012236936-2026-000269
• Device Sequence Number: 16099909
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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: Phaco System, Tip, Tubing Pack.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown