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

Model Number PI-RET

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  malfunction  

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.Device evaluation: two (2) patient interface (pi) lot# 60137580 was returned within its original packaging.A visual inspection of the returned devices did not reveal any damage to the components and all parts were assembled correctly.Suction and dimensional test were performed, and all results were within specifications.The reported suction loss issue could not be confirmed.Manufacturing record evaluation: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the pi lot# 60137580.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The surgery center reported suction loss during surgery.The suction ring assembly with an intralase patient interface (pi) occurred after the patient was applanated and after laser fired.It was noted that (1) one flap/ring procedure was replaced and the surgery was completed successfully.There was no patient injury reported and no surgical intervention was required.This report is 1 of 2.

Manufacturer Narrative

The manufacturer report number should have been 3006695864.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.; santa ana CA 92705
• MDR Report Key: 7993620
• MDR Text Key: 126231600
• Report Number: 3008169506-2018-00101
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(17)200709(10)60137580
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Model Number: PI-RET
• Device Catalogue Number: 590106AN
• Device Lot Number: 60137580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• 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: 09/28/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 10/22/2018; 10/25/2020
• Supplement Dates FDA Received: 10/22/2018; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMTO LASER SERIAL NUMBER: (B)(6).