MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. INTRALASE; PATIENT INTERFACE

Model Number 590106AN

Device Problem Decrease in Suction (1146)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date is unavailable at the time of this report.Manufacturing date is unavailable at the time of this report.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

The surgeon reported that he experienced suction loss from the beginning of docking and then the loss of suction moved in during the side cut.The surgeon switched out the patient interface (pi) and re-applied suction and performed a side cut only.The laser application was successful.Both eyes were completed as scheduled.No further medical intervention was necessary.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: INTRALASE
• Type of Device: PATIENT INTERFACE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9576406
• MDR Text Key: 175197870
• Report Number: 3006695864-2020-00046
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• 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: 01/01/2005,11/04/2020

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMTOSECOND LASER, SERIAL NUMBER: (B)(6)
• Patient Age: 21 YR