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  

Event Description

This report summarizes 276 malfunction events.The events were related to suction loss during laser fire.There were no patient injuries reported associated to the events.

Manufacturer Narrative

Lot numbers of the devices and quantity: 60328672 (x14), 60296764 (x12), 60333690 (x12), 60341112 (x11), 60357170 (x10), 60383020 (x9), 60379006 (x9), 60389491 (x9), 60298837 (x9), 60323225 (x9), 60317391 (x8), 60375374 (x8), 60396479 (x8), 60355767 (x8), unknown (x8), 60311912 (x6), 60376065 (x6), 60343419 (x6), 60320253 (x6), 60332109 (x5), 60348567 (x5), 60390926 (x5), 60403113 (x5), 60343189 (x5), 60394053 (x4), 60370558 (x4), 60336893 (x4), 60309863 (x4), 60358903 (x4), 60358902 (x3), 60303339 (x3), 60330262 (x3), 60371231 (x3), 60343420 (x3), 60383021 (x3), 60401425 (x3), 60388200 (x3), 60389250 (x3), 60377741 (x3), 60375573 (x3), 60347301 (x3), 60394054 (x2), 60405221 (x2), 60403114 (x2), 60377739 (x2), 60385030 (x2), 60347544 (x2), 60287678 (x1), 60264642 (x1), 60292889 (x1), 60141169 (x1), 60298836 (x1), 60297881 (x1), 60377740 (x1), 60311315 (x1), 60336894 (x1), 60319241 (x1), 60324362 (x1), 60271092 (x1), 60301370 (x1), 60338314 (x1), 60323882 (x1).One hundred and fifty nine investigations were completed during the period.From those the following was found: ten products were returned incomplete, four products were returned broken and 1 was found to have an operational problem.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.

Manufacturer Narrative

Device evaluation: fifty (53) investigations were completed during the period.No product deficiency was identified.For 7 investigations the product evaluation was not possible because the product was received loose inside the box and individual product components could not be associated with their corresponding complaint events, lot numbers, or complaint/investigation files.For 4 investigations the device was received incomplete, for 1 the device was 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: 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
• 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: 16261012
• MDR Text Key: 308507655
• Report Number: 3012236936-2023-00190
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 276
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2023

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: 590106AN
• Device Catalogue Number: 590106AN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 04/28/2023; 07/28/2023
• Supplement Dates FDA Received: 04/29/2023; 07/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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