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

Model Number	0180-1201
Medical Device Problem Codes	Decrease in Suction (1146); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a loss of suction.The procedure was successfully completed with another interface.According to the doctor, this unit had a steeper tubing inclination than the others.Through follow-up, it was confirmed that the suction loss occurred during laser firing.No additional information was received.
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 d6a - implant date: not applicable.The loi is not an implantable device.Section d6b - explant date: not applicable.The loi is not an implantable device; therefore, not explanted.Section e1 - first/given name: unknown, as information was requested but not provided section e1 - telephone number: (b)(6).Section h3 - other (81): the material was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Note: this event was initially submitted under report 3012236936-2023-02749, vmsr-0000038, submitted on october 29th, 2023.Upon further review it was determined that the event did not qualify as a vmsr event.
Additional Manufacturer Narrative
Correction: h4: correction: in initial report, the manufacturer date provided was inadvertently reported as 03/04/2023, however the correct date is 04/03/2023.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: 05-jan-2024.Section h3: device evaluated by manufacturer? yes.Device evaluation: 1 of the reported 1 opened liquid optics interface received within original packaging confirming the reported lot number.A visual inspection of the returned product did not reveal any obvious defects or damage.Functionality tests were performed, and the results were found within specifications.The reported event cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18177342
• Report Number: 3012236936-2023-02906
• Device Sequence Number: 7598105
• Product Code: OOE
• UDI-Device Identifier: 05050474609778
• UDI-Public: (01)05050474609778(17)240401(10)22062553
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 04/01/2024
• Device Model Number: 0180-1201
• Device Catalogue Number: 0180-1201
• Device Lot Number: 22062553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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: CATALYS SYSTEM S/N: (B)(6).
• Patient Sex: Unknown