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 222 malfunction events.The events were related to suction loss while laser firing.There were no patient injuries reported associated to the events.

Manufacturer Narrative

Lot numbers of the devices and quantity: 60430797 (x 40).60429451 (x15).60466811 (x12).60433661 (x12).60438010 (x10).60428229 (x8).60444547 (x8).60475840 (x8).60452938 (x7).60429449 (x7).60438011 (x7).60487821 (x6).60432227 (x6).60440257 (x5).60435937 (x5).60438012 (x5).60493225 (x4).60465454 (x3).Uknown (x5).60442467 (x3).60483039 (x3) 60444546 (x3).60428228 (x2).60341783 (x2).60475839 (x2).60442468 (x2).60320253 (x2).60397718 (x2).60475838 (x2).60403114 (x2).60438013 (x2).60452939 (x2).60432228 (x2).60454686 (x2).60444545 (x1).60506730 (x1).60338314 (x1).60454687 (x1).60435021 (x1).60383020 (x1).60415092 (x1).60348567 (x1).60477945 (x1).60466812 (x1).60390024 (x1).60468464 (x1).60425406 (x1).60471936 (x1).60425407 (x1).60343420 (x1).60426325 (x1).One hundred and five (105) investigations were completed during the period.A review of the records related to the device model 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 was identified.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

Eltwenty-six (26) 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 was performed.A review of the device history record (dhr) showed that the system and its components met all specifications prior to being released.No product deficiency was 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: 18611335
• MDR Text Key: 334179829
• Report Number: 3012236936-2024-00216
• 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: 223
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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
• 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