MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON GV PRO; OVDS

Model Number TG85ML

Device Problem Contamination (1120)

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The healon is not an implantable device.If explanted; give date: n/a (not applicable).The healon is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that some microfibers (sometimes white, sometimes black ¿ size about 2mm) were found in the eye.These are found just after the healon is introduced into the eye, in the anterior chamber, prior to the capsular hexis.The surgeon says the healon is responsible for the issue.No additional information was provided.Two events were reported.This report represents the second report.

Manufacturer Narrative

G9: correction: in review, of medwatch 3004750704-2019-00085 and per new information received, this event has been assessed not reportable due the fact that customer did not longer belief that particles came from a jnj product.There will be no more information provided for mfg reporting no.3004750704-2019-00085.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: HEALON GV PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9332633
• MDR Text Key: 186750494
• Report Number: 3004750704-2019-00085
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609631
• UDI-Public: (01)05050474609631(17)220831(10)UE31499
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: TG85ML
• Device Catalogue Number: 10270012
• Device Lot Number: UE31499
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1