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
Event or Problem Description
This report summarizes 4 malfunction events.The event was related to suction loss while laser firing.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
One investigation was completed during the reporting period.A review of the records related to the device that included labeling, manuals, trending, risk documentation and device history record (dhr) was performed and showed that the device and its components met all specifications prior to being released.No product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: in the initial report the lot numbers of the devices and quantity were inadvertently not included.Below is the list of lot numbers for the 4 events reported: unknown (x2) 22751514, 20644671.
Additional Manufacturer Narrative
Additional information one (1) investigation was 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 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
Additional information: one (1) investigation was 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: product was received with other products in a box.They were received loose within package and individual product components could not be associated with their corresponding lot numbers, complaint events, or complaint files.Product evaluation could not be performed.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18581962
• Report Number: 3012236936-2024-00204
• Device Sequence Number: 8203494
• 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: 4
• 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,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; Not provided; Not provided
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 01/25/2024; 04/24/2024; 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