MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIQUID OPTICS INTERFACE; OPHTHALMIC FEMTOSECOND LASER

Model Number	0180-1401
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
List of all lot numbers of the devices and quantity.21937847 (x1).19054113 (x3).Unknown (x2).22751516 (x1).22751514 (x1).22964037 (x1).23223768 (x1).No investigations were completed during the period.
Event or Problem Description
This report summarizes 10 malfunction events.The events were related to suction loss during laser fire.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Additional information: nine (9) investigations were completed during the period.A review of the records related to the device that included labeling, manuals, trending, risk documentation and device history record (dhr) showed that the system and its components met all specifications prior to being released.No product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: one (1) investigation was completed during the period.Product was received within original packaging confirming the reported lot number.A visual inspection of the product did not reveal any obvious defects or damage.Loi vacuum test performed also passed.A review of the records related to the device that included labeling, manuals, trending, risk documentation and device history record (dhr) showed that the device and its components met all specifications prior to being released.No product deficiency was identified.

• Brand Name: LIQUID OPTICS INTERFACE
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19177867
• Report Number: 3012236936-2024-01224
• Device Sequence Number: 7232342
• Product Code: OOE
• UDI-Device Identifier: 05050474609761
• UDI-Public: (01)05050474609761
• Combination Product (Y/N): N
• PMA/510(K) Number: K170322
• Number of Events Summarized: 10
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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
• Device Model Number: 0180-1401
• Device Catalogue Number: 0180-1401-11
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/26/2024; 10/22/2024
• 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