MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC INTRALASE; PATIENT INTERFACE

Model Number 590106AN

Device Problems Decrease in Suction (1146); Use of Device Problem (1670)

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

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

When reviewing the product identification it was noticed that the product was used after its expiration date.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.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 by the customer that they experienced suction loss with the product interface during laser firing.Procedure was completed successfully.There was no patient injury or surgical intervention needed.

Manufacturer Narrative

Section d9: device available for evaluation: yes , returned to manufacturer on 11 jan 2021.Section h3: device returned to manufacturer: yes.Device evaluation: per returned tyvek lid and dhr record, this product expired on 07-09-2020, prior to the event date, therefore no testing will be performed on expired product.The reported event cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the patient interface were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this lot number have been received.Conclusion: 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.

Manufacturer Narrative

Corrected data: section h6: medical device problem code as part of an internal review of our mdrs it was identified that the code 1670 (expired product used) was not provided on the initial report.This report is being submitted to include code 1670.Section h6: component code added: 4755.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: INTRALASE
• Type of Device: PATIENT INTERFACE
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood dr; milpitas, CA 92879 ; 7142478552
• MDR Report Key: 11135714
• MDR Text Key: 225774006
• Report Number: 3006695864-2021-07023
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(17)200709(10)60137580
• 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 Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2022

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: 07/09/2020
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Device Lot Number: 60137580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 10/13/2022
• Supplement Dates FDA Received: 03/16/2021; 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1