MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	660065AN
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a visual inspection of the returned product did not reveal any obvious defects or damage.The syringe was not returned, therefore functional testing could not be performed.A review of the device history record (dhr) showed all devices meet material, assembly, and performance specifications at the time of product release.No product deficiency was identified.The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 1 malfunction event.The events were related to suction loss during laser fire.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Corrected data: in the initial summary report the word "vmsr" was not included in the exemption/variance number field.During a review of a case it was found the lot number and model was incorrect.This changes the information provided in the initial report and the following fields are not blank/empty since there are 2 devices as part of the summary report: d4 - expiration date.D9 - device availability.D9 - return to manufacturer.D9 - date returned to manufacturer.E1 initial reporter information section (title, first name, last name, establishment name, country, address line 1, city, state, zip code).E2 - health professional? initial reporter also sent the report to fda? g4 device manufacture date.In addition the field d4 - primary unique device identification (udi) number is now a partial number, (b)(4), as there are 2 devices in the summary report the no.Of events summarized is now 2 and the lot number being added to the list of affected devices is 60429453.Device evaluation: one (1) investigation was completed during the reporting period and it was related to the device mentioned above, lot 60429453.The device was not returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of records including device history and complaint trending was performed.Records showed device met specifications prior to being released.No product deficiency was identified.All pertinent information available to johnson & johnson.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 21220036
• Report Number: 3012236936-2025-000015
• Device Sequence Number: 11654798
• Product Code: HNO
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060372
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 07/20/2026
• Device Model Number: 660065AN
• Device Catalogue Number: 660065AN
• Device Lot Number: 60582341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• 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: Unknown