MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	660065AN
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 60382514 (x2).60335190 (x3).Two (2) 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.The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 5 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 - it was initially reported there were 5 events however, the correct number of events is 6.The lot number of the product is 60335190.In the initial report is was also indicated that the amount of events involving this lot number were 3 however, with the correction on the number of events this amount is also being corrected.The total number of events for lot number 60335190 is 4.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: three (3) 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.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 15695649
• Report Number: 3012236936-2022-02717
• Device Sequence Number: 7272103
• Product Code: HNO
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305
• Combination Product (Y/N): N
• PMA/510(K) Number: K060372
• Number of Events Summarized: 5
• 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): 01/25/2023

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
• Device Model Number: 660065AN
• Device Catalogue Number: 660065AN
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 01/24/2023; 01/25/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/24/2023; 01/25/2023
• 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