MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SOLO; CANNULA, OPHTHALMIC

Model Number	OPOIA2045D
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, as information was requested, and not provided.Section b3 date of event: unknown/not provided.Section d4: lot #: unknown/not provided.Section d4: model # unknown/not provided.Section d4: catalog # unknown/not provided.Section d4: expiration date: unknown, as the serial number of the device was not provided.Section d4: udi #: a complete udi # is unknown as product serial number was not provided.Section d6a: if implanted, give date: not applicable, as the irrigation/aspiration tip is not an implantable device.Section d6b: if explanted, give date: not applicable, as the irritation/aspiration tip is not an implantable device.Section h3: the irrigation/aspiration tip 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.Section h4.Device manufacture date: unknown, as the serial number of the device was not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer reported that the tip of their ia handpiece broke off and requested a replacement.No further information provided.
Additional Manufacturer Narrative
Section h11: additional data, additional information was received, customer reported the solo lot # 071575 (opoia2045d - i/a hp 20 ga 45 degree silicone sleeve tip.) was tip with the issue.Section d1: brand name, solo.Section d2: d2a.Common device name, cannula, ophthalmic.Section d2: d2b.Device product code, hmx.Section d4: model number, opoia2045d.Section d4: catalog number, opoia2045d.Section d4: lot number, 071575.Section d4: primary unique device identification (udi) number (b)(4).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: SOLO
• Common Device Name: CANNULA, OPHTHALMIC
• 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: 21068615
• Report Number: 3012236936-2025-000002
• Device Sequence Number: 8409463
• Product Code: HMX
• UDI-Device Identifier: 05050474521049
• UDI-Public: (01)05050474521049(17)991231(10)071575
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Model Number: OPOIA2045D
• Device Catalogue Number: OPOIA2045D
• Device Lot Number: 071575
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: IRRIGATION/ASPIRATION HANDPIECE SN UNKNOWN
• Patient Sex: Prefer Not To Disclose