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 12/20/2019

Event Type  Injury  

Manufacturer Narrative

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 subsequent to suction loss, he observed an incomplete side cut occurring nasally as he was attempting to score along the side cut to lift the flap.Flap diameter was 9.0 mm.The surgeon was unable to lift flap and stated that the flap seemed thin in area where he could lift temporally.He aborted the flap lift and converted to photorefractive keratectomy (prk).Idesign excimer treatment was completed successfully.

Manufacturer Narrative

A2 - patient age was omitted in initial report.Patient is 39 years old.A3 - patient sex was omitted in initial report.Patient is male.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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: 9576539
• MDR Text Key: 174951770
• Report Number: 3006695864-2020-00047
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(17)210319(10)60176686
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Device Lot Number: 60176686
• 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: 12/20/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 10/25/2020
• Supplement Dates FDA Received: 03/18/2020; 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 Outcome(s): Required Intervention
• Patient Age: 39 YR