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

Model Number 590106AN

Device Problem Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Lot numbers of the devices and quantity 60429449 x17 60452938 x12 60454686 x12 60442467 x11 60429451 x8 60465454 x5 60426324 x5 60440257 x5 60452939 x4 60442468 x4 60403114 x4 60444545 x4 60415092 x4 60432228 x4 60438011 x3 60477945 x3 60417230 x3 60390926 x3 60435019 x3 60438010 x3 60444546 x2 60333690 x2 60401427 x2 unknown x2 60425406 x2 60417232 x2 60347301 x1 60403113 x1 60358903 x1 60438012 x1 60368822 x1 60438013 x1 60385030 x1 60440255 x1 60433663 x1 one hundred and ten investigations were completed during the period.Four products were returned incomplete.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 devices and its components met all specifications prior to being released.The risks and mitigation's 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 Description

This report summarizes 138 malfunction events.The events were related to suction loss during laser fire.There were no patient injuries reported associated to the events.

Manufacturer Narrative

Device evaluation: seven (7) investigations were completed during the reporting period.A review of the records related to the device that included labeling, manuals, trending, risk documentation and device history record (dhr) was performed and showed that the devices and its components met all specifications prior to being released.No product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: FS DISPOSABLE INTERFACE
• Type of Device: 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: 18033176
• MDR Text Key: 326907484
• Report Number: 3012236936-2023-02745
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 138
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1