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 240 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: 60341112 (x 18), unknown (x 14), 60343189 (x 13), 60338314 (x 13), 60357170 (x 12), 60379006 (x 10), 60332109 (x 10), 60371231 (x 9), 60343419 (x 9), 60327645 (x 8), 60375374 (x 7), 60347544 (x 7), 60333690 (x 6), 60377740 (x 6), 60358902 (x 6), 60347300 (x 5), 60376065 (x 5), 60357624 (x 5), 60358903 (x 5), 60347543 (x 5), 60292889 (x 4), 60368822 (x 4), 60319240 (x 4), 60358905 (x 4), 60336893 (x 4), 60377741 (x 3), 60343420 (x 3), 60336894 (x 3), 60330263 (x 3), 60341113 (x 3), 60388199 (x 2), 60287678 (x 2), 60319241 (x 2), 60324362 (x 2), 60323882 (x 2), 60327630 (x 2), 60330262 (x 2), 60324359 (x 2), 60332108 (x 1), 60381549 (x 1), 60297881 (x 1), 60301370 (x 1), 60385030 (x 1), 60303339 (x 1), 60355767 (x 1), 60294306 (x 1), 60325739 (x 1), 60320254 (x 1), 60383021 (x 1), 60323225 (x 1), 60317514 (x 1), 60276236 (x 1), 60377739 (x 1), 60334442 (x 1).One hundred and five (105) 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.
Additional Manufacturer Narrative
Device evaluation: seventy investigations were completed during the period and the findings were as follow: two devices had operational problems - one of them a misshaped and bent suction ring edges and when functionally tested it did not met specification.The second one failed the functional tested as the syringe would not stay depressed and vacuum pressure gradually decreased.One device was returned incomplete and testing could not be performed.Sixty seven devices were found within specification.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.
Additional Manufacturer Narrative
Correction - it was initially reported there were 240 events however, it was found there were 242 events.This also changed quantity for the unknown lot number events from 14 to 16 as both events were for unknown lot numbers.
Additional Manufacturer Narrative
Device evaluation: two (2) investigations were completed during the period.No product deficiency was identified.For one of the devices it arrived 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.

• 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: 15697614
• Report Number: 3012236936-2022-02720
• Device Sequence Number: 17819172
• 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: 240
• 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): 04/28/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2022
• Supplement Date Received by Manufacturer: 01/27/2023; 01/27/2023; 04/28/2023
• Initial Report FDA Received Date: 10/30/2022
• Supplement Report FDA Received Date: 01/27/2023; 01/27/2023; 04/28/2023
• 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