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 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth, weight, ethnicity: unknown/not provided.Email and first/given name: unknown, not provided.The device was not returned for analysis.There was no model/lot/serial number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.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 pi during 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
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 12086435
• MDR Text Key: 259029772
• Report Number: 3006695864-2021-07906
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/29/2021

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: UNK-PATIENT INTERFACE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/29/2021
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: SN: (B)(4)