MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number UNKNOWN

Device Problem Decrease in Suction (1146)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product lot number was not provided.A partial number has been provided device manufacture date: unknown, as the lot number of the device was not provided reporter's email address: unknown/not provided.At the time of the investigation, product was not available for evaluation as the surgical procedure was completed with the same product.Therefore, no testing could be performed.The reported event cannot be confirmed.For this reported event, lot# was not reported and cannot be obtained.Therefore, manufacturing record review cannot be performed.Based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.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

It was reported by the customer that they experienced suction loss with the patient interface(pi) during the laser firing.Procedure was completed successfully with the same pi.There was no patient injury or surgical intervention needed.

• Brand Name: FS DISPOSABLE INTERFACE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 12677699
• MDR Text Key: 278152240
• Report Number: 2020664-2021-07814
• 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: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/21/2021

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 Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: 590106AN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1