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

Model Number 0180-1201

Device Problems Decrease in Suction (1146); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: LIQUID OPTICS INTERFACE
• Type of Device: 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
• MDR Text Key: 329789310
• Report Number: 3012236936-2023-02906
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Device Identifier: 05050474609778
• UDI-Public: (01)05050474609778(17)240401(10)22062553
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATALYS SYSTEM S/N (B)(6).