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 240 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: 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.

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.

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.

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
• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15697614
• MDR Text Key: 306816183
• Report Number: 3012236936-2022-02720
• 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: 240
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 10/30/2022
• Initial Date FDA Received: 10/30/2022
• Supplement Dates Manufacturer Received: 01/27/2023; 01/27/2023; 04/28/2023
• Supplement Dates FDA Received: 01/27/2023; 01/27/2023; 04/28/2023
• 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