MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_PATIENT INTERFACE; KERATOME, AC-POWERED

Model Number UNK-PATIENT INTERFACE

Device Problem Decrease in Suction (1146)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: unknown/ not provided.Lot#: unknown/not provided.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.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided.Conclusion: as a result of the investigation and based on limited information available, it cannot be determined if there is a product malfunction.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 patient squeezed and they experienced suction loss with the patient interface during the laser firing.Procedure was completed successfully.There was no patient injury or surgical intervention needed.

• Brand Name: UNK_PATIENT INTERFACE
• Type of Device: KERATOME, AC-POWERED
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 12477678
• MDR Text Key: 273879728
• Report Number: 2020664-2021-07262
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688
• Combination Product (y/n): N
• 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: 09/15/2021

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: UNK-PATIENT INTERFACE
• 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: 08/20/2021
• Initial Date FDA Received: 09/15/2021
• 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: Reuse
• Patient Sequence Number: 1