MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC LIQUID OPTICS INTERFACE; OPHTHALMIC FEMTOSECOND LASER

Model Number	0180-1201
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: not applicable.Section d6a: if implanted, give date: not applicable, as device is not an implantable device.Section d6b: if explanted, give date: not applicable, as device 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 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: not available at the time to this report.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the outer packaging was intact, however the inner packaging of the patient interface was not and the kit was compromised.No additional information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes, returned to manufacturer on oct 18, 2024.Section h3: device evaluated by manufacturer: yes.Section h6: component codes - 4747.Section h6: type of investigation - 3331, 4109.Section h6: investigation findings - 111.Section h6: investigation conclusions - 4310.Device evaluation: one opened liquid optics interface was received within original packaging confirming the reported lot number.A visual inspection of the returned product did not reveal any obvious defects or damage.The inner packaging consisting of the tray and tyvek lid were further inspected; the tyvek lid was still attached to one side of the tray and the adhesive residue can be seen along the entire tray where the tyvek lid was attached.The outer packaging box does no indicate any defects or damage.The reported event is confirmed.Manufacturing record review: the external manufacturer performed a review of their records.There were no causes related to manufacturing identified.The lot did not include any non-conformances or deviations during the manufacturing process.All equipment calibration is within calibration due date.Conclusion: the probable cause was that the unit was accidentally packaged in the chipboard box after the tyvek was opened.The process has been reviewed.There are no manufacturing related causes or process improvement opportunities identified.Therefore no further failure investigation is required.All pertinent information available to johnson & johnson surgical vision, inc.Has been provided.

• Brand Name: LIQUID OPTICS INTERFACE
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• 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: 20476937
• Report Number: 3012236936-2024-000281
• Device Sequence Number: 18043207
• Product Code: OOE
• UDI-Device Identifier: 05050474609778
• UDI-Public: (01)05050474609778(17)260515(10)24391952
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K170322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 05/15/2026
• Device Model Number: 0180-1201
• Device Catalogue Number: 0180-1201
• Device Lot Number: 24391952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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