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

Model Number 590106AN

Device Problem Decrease in Suction (1146)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

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.As partial number has been provided device manufacture date: unknown, as the lot number of the device was not provided.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 suction was lost about 1 second into the procedure, so dr realigned, but once it was cancelled it took 1 procedure- cone was still used.There was no patient injury or surgical intervention needed.

Manufacturer Narrative

Device evaluation: product was not available for further evaluation.Therefore, no testing could be performed.The reported event cannot be confirmed.Manufacturing records review: the lot number was not reported and cannot be obtained.Therefore, complaint history review cannot be performed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
• MDR Report Key: 11158289
• MDR Text Key: 226539077
• Report Number: 3006695864-2021-07031
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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: 590106AN
• 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: 12/15/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1