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

Model Number	0180-1201
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
B5 - this report summarizes 24 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
Correction: there was a typographical error on the quantity of events reported in the initial report.The correct number of events is 24 and not 22 as initially reported.Therefore, b5 and h1 - no.Of events fields are being updated as follows: b5 - this report summarizes 24 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
Lot numbers of the devices and quantity: 22595450 (x4) 22963653 (x2) uknown (x2) 22255670 (x1) 23246667 (x1) 23121217 (x1) 22595446 (x1) 22903420 (x1) 22255650 (x1) 23121213 (x1) 22815140 (x1) 23121235 (x1) 23520807 (x1) 22499916 (x1) 22062543 (x1) 22844416 (x1) four (4) investigations were 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 system 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.
Event or Problem Description
This report summarizes 22 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
Correction: the total amount of events related to lot 23121235 are 3 and not 1 as originally reported.
Additional Manufacturer Narrative
Correction: in supplemental #2 h1 field was inadvertently left blank.The field should have included the number 24.
Additional Manufacturer Narrative
Device evaluation fourteen (14) 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 its components met all specifications prior to being released.For 2 devices the dhr could not be performed as the lot number was not provided.No product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: two (2) 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 device 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
Follow up number 5 was submitted without h2 completed.The h2 field for supplemental #5 should have been marked as "device evaluation.".

• 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: 19177728
• Report Number: 3012236936-2024-01222
• Device Sequence Number: 20683414
• Product Code: OOE
• UDI-Device Identifier: 05050474609778
• UDI-Public: (01)05050474609778
• Combination Product (Y/N): N
• PMA/510(K) Number: K170322
• Number of Events Summarized: 24
• 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): 10/29/2024

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: 0180-1201
• Device Catalogue Number: 0180-1201-11
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 04/24/2024; 04/24/2024; 07/19/2024; 07/25/2024; 10/28/2024; 10/29/2024
• 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