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

Model Number	UNK-PATIENT INTERFACE
Medical Device Problem Codes	Decrease in Suction (1146); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the patient interface (pi) the surgeon found the device to be very stiff which made placement challenging.Due to this, the device would not maintain suction so was replaced with a back up.The surgeon also reported the replacement device to be very stiff.There was no patient injury and the procedure was completed without further issue.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4: lot number: unknown/not provided.Section d4: model # unknown/not provided.Section d4: catalog # unknown/not provided.Section d4: expiration date: unknown, as the lot number of the device was not provided.Section d4: udi #: a complete udi # is unknown as product lot number was not provided.Section d6a - implant date: not applicable to suspect device.Section d6b - explant date: not applicable to suspect device.Section e1 - first/given name: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).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 this review, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the lot number of the device was not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25326464
• Report Number: 3012236936-2026-000125
• Device Sequence Number: 9806274
• Product Code: GEX
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: UNK-PATIENT INTERFACE
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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