MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON ENDOCOAT; AID, SURGICAL, VISCOELASTIC

Model Number	VT585U
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as the healon is not an implantable device.Section d6b: if explanted, give date: not applicable, as the healon is not an implantable device.Section h3-other (81): the healon endocoat was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, 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 seeing a small blue fiber in the healon endocoat that was injected for the case.The healon used for the case had been disposed of in their sharps container.No further information provided.

• Brand Name: HEALON ENDOCOAT
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• 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: 21327171
• Report Number: 3012236936-2025-000028
• Device Sequence Number: 20812709
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)250930(10)030500
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 030500
• 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: 01/08/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose