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
Lot numbers of the devices and quantity: unknown (3x), 19975710 (2x), 20644672 (1x), 20644670 (1x), 20644671 (1x), 19975711 (1x), 20694877 (1x), 20198649 (1x), 19327844 (1x), 20440356 (1x).Twelve (12) investigations were completed during the period.A review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.A review of the 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 13 malfunction events.The event was related to suction loss during laser firing.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Additional information: one (1) investigation was completed during the period.No product deficiency was identified.A review of the records related to the device that included labeling, manuals, trending, and risk documentation reviews was performed.A review of the device history record (dhr) showed that the device and its components met all specifications prior to being released.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.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): 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: 17420560
• Report Number: 3012236936-2023-01951
• Device Sequence Number: 13017992
• 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: 13
• 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): 10/30/2023

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 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: 07/28/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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