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
H10 -list of all lot numbers of the devices and quantity.23223767 (x1).Unknown (x2).Two (2) investigations were completed during the period.A review of the records related to the device that included labeling, 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.
Event or Problem Description
This report summarizes 3 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
Corrected data: in the initial summary report the word "vmsr" was not included in the exemption/variance number field.Manufacturer narrative - device evaluation: one (1) investigation was completed during the reporting period.The device was not returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of records including device history and complaint trending was performed.Records showed device met specifications prior to being released.No product deficiency was identified.All pertinent information available to johnson & johnson.

• 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: 21175304
• Report Number: 3012236936-2025-000015
• Device Sequence Number: 4300774
• Product Code: OOE
• UDI-Device Identifier: 05050474609761
• UDI-Public: (01)05050474609761
• Combination Product (Y/N): N
• PMA/510(K) Number: K170322
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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
• 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
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/18/2025
• 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