MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	660065AN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint pertains to an intraoperative event of vertical gas breakthrough reported by the customer.While the first eye was successfully treated, the flap on the second eye could not be lifted due to the escape of gas bubbles.The certified surgeon, observed the gas breakthrough and sought clarification regarding the appropriate timeframe for performing the photorefractive keratectomy (prk) procedure on the affected eye.Our clinical application specialist (cas) explained that there is no specific recommendation for the timeframe, leaving the decision to the surgeon's discretion, and advised against lifting the flap in such situations.No intraoperative intervention necessary.Flap was not lifted.No medication outside the standard of care was prescribed.Customer used an expired patient interface on this procedure.Patient outcome after the prk procedure was 20/30-2, with pin hole 20/20+1 on the first day following surgery.Note: this is report 2 of 2.
Additional Manufacturer Narrative
Section a4: information was requested but it is unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the system is not an implantable device.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.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 22290212
• Report Number: 3012236936-2025-000168
• Device Sequence Number: 8875824
• Product Code: GEX
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305(17)241030(10)60415449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K060372
• 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): 06/18/2025

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 Expiration Date: 10/30/2024
• Device Model Number: 660065AN
• Device Catalogue Number: 660065AN
• Device Lot Number: 60415449
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IFS SERIAL NUMBER (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian