MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ELLIPS FX PHACO HANDPIECE

Model Number 690880

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The account reported that the handpiece got warm during priming.No further information was provided.

Manufacturer Narrative

H4: correction: manufacturer date: 11/3/2015.Additional information: section d10.Device available for evaluation? yes.Returned to manufacturer on: 9/4/2019.Section h3.Device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.The handpiece was evaluated.Per evaluation report, no issue could be found with the performance of handpiece.The device operated as expected.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.The risk management files and trending were reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.No labeling change is required.The review of the device history record (dhr) for ellips fx phaco handpiece showed that there were no related issues or related non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.The handpiece is working within j&j specifications.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-(b)(4).And capa-010215.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: PHACO HANDPIECE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8964511
• MDR Text Key: 156607244
• Report Number: 3006695864-2019-00712
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPACT INTUITIV CONSOLE, SERIAL # (B)(6) .; COMPACT INTUITIV CONSOLE, SERIAL # (B)(4)