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

Model Number 590106AN

Device Problem Decrease in Suction (1146)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

Contact name is unknown as it was not provided.Phone: (b)(6).The patient interface is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that suction loss during laser firing.No patient injury.Procedure was completed.Product was not available for evaluation.No further information available.

Manufacturer Narrative

Corrected data: in review of section e in follow-up 1, the country was inadvertently selected as united states, however, the country should have been united kingdom all pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

Correction: section g8: the manufacturer report number should have been 3006695864.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): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11178729
• MDR Text Key: 241745509
• Report Number: 2648035-2021-07084
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(17)210711(10)60193344
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

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 Expiration Date: 07/11/2021
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Device Lot Number: 60193344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/15/2021; 03/08/2021
• Supplement Dates FDA Received: 01/20/2021; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1