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 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: at the time of the investigation, product was not available for evaluation - according to the cp file the product was discarded.No testing could be performed.The reported event cannot be confirmed.For this reported event, lot# was not reported and cannot be obtained.Therefore, complaint history review cannot be performed.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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that a suction loss after the laser fired occurred using a patient interface with an unknown lot number.The procedure was completed successfully by using the same patient interface.No patient injury or surgical intervention was required.

• Brand Name: UNK_PATIENT INTERFACE
• Type of Device: KERATOME, AC-POWERED
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 11963280
• MDR Text Key: 264964563
• Report Number: 3006695864-2021-07879
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

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/NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/08/2021
• 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