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); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were difficulties in inserting the liquid optical interface (loi) and there was suction loss.Through follow-up, we learned that the suction loss occurred during the laser firing.The procedure was temporarily aborted and then resumed as a standard cataract surgery.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 liquid optics interface is not an implantable device.Section d6b - explant date: not applicable.The liquid optics interface is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Device evaluation: the liquid optics interface (loi) was not returned for evaluation as it was discarded.Therefore, a failure analysis of the complaint device could not be completed.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 and the reported issue could not be verified.All pertinent information available to johnson & 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: 18076423
• Report Number: 3012236936-2023-02669
• Device Sequence Number: 12685763
• Product Code: OOE
• UDI-Device Identifier: 05050474609778
• UDI-Public: (01)05050474609778(17)240319(10)22062543
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2023

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: 03/19/2024
• Device Model Number: 0180-1201
• Device Catalogue Number: 0180-1201
• Device Lot Number: 22062543
• 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: 10/10/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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 S/N - 44104315
• Patient Sex: Unknown