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

Model Number	590106AN
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 298 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
Lot numbers of the devices and quantity: 60438013 (26x), 60435019 (22x), 60428229 (18x), 60438011 (16x), 60442468 (16x), 60415091 (15x), 60444546 (15x), 60444547 (14x), 60442467 (11x), 60429451 (11x), 60429450 (9x), 60426324 (8x), 60440257 (8x), 60428228 (8x), 60435937 (8x), 60413128 (8x), 60410165 (7x), 60433663 (6x), 60432228 (5x), 60425407 (5x), 60430797 (4x), 60438012 (4x), 60358902 (3x), 60417230 (3x), 60403114 (3x), 60292889 (3x), unknown (3x), 60410164 (2x), 60377741 (2x), 60410167 (2x), 60454686 (2x), 60379005 (2x), 60415092 (2x), 60444545 (2x), 60426325 (2x), 60429449 (2x), 60389491 (2x), 60389250 (2x), 60432227 (2x), 60394053 (1x), 60324359 (1x), 60425406 (1x), 60394054 (1x), 60488013 (1x), 60401425 (1x), 60442471 (1x), 60358903 (1x), 60417231 (1x), 60388200 (1x), 60429441 (1x), 60406576 (1x), 60390925 (1x), 60417232 (1x), 60298836 (1x).H6 -investigation findings - 4247 - appropriate term/code not available (for broken).One hundred-twenty investigations were completed during the period.No product deficiency was identified.Five products were returned incomplete and 3 were returned broken.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.
Additional Manufacturer Narrative
Device evaluation: one hundred and eleven investigations were completed during the period.Ninety-two patient interfaces were returned and nineteen were not.From the ninety-two patient interfaces that were returned eighty-one had no issues identified, eight were returned incomplete and 3 were returned damaged/broken.No product deficiency was identified.A review of the records related to the device model that included labeling, manuals, trending, and risk documentation reviews was performed.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.
Additional Manufacturer Narrative
Correction: it was inadvertently reported in the initial report there were 3 devices with unknown lot numbers however, there was only 1 device for the unknown lot number and 2 devices were for lot number 603000234.The amount of events remain the same.
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 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.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 17421437
• Report Number: 3012236936-2023-01955
• Device Sequence Number: 17925831
• 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: 298
• 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
• Report Date (Section B): 07/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• 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: 10/27/2023; 10/27/2023; Not provided
• Initial Report FDA Received Date: 07/29/2023
• Supplement Report FDA Received Date: 10/27/2023; 01/26/2024; 07/26/2024
• 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