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

Model Number TG85ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Intraocular Pressure Increased (1937); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date not provided only (b)(6) 2019.(b)(6).Implant and explant date: if implanted or explanted; give date: n/a (not applicable).The viscoelastic (ovd) is not an implantable device; therefore, not explanted.(b)(4).This complaint is part of the recall - report number 2020664-12/02/19-001-r: johnson & johnson surgical vision (jjsv) issued a voluntary recall on november 22, 2019.It has been reported customers have described healon gv pro as behaving differently than the legacy healon gv, especially in regard to the techniques required to remove the product from the eye.An increase of intra-ocular pressure (iop) is reported if there are small amounts of healon gv pro remaining behind the operative eye.This voluntary recall is being initiated due to received reports of healon gv pro being difficult to remove from the eye, leading to increased post-operative iop requiring additional intervention.Potential clogging of phacoemulsification equipment tubing has also been reported, which may lead to delay in the procedure or ocular injury.There are twenty-one affected lot numbers.The recall notification letter has been sent to all customers instructing them to return the units of healon gv pro from the twenty-one (21) affected lots.Johnson & johnson surgical vision has initiated a corrective and preventative actions (capa) to investigate and address the issue.Action items generated from the capa will be submitted in the future interim report(s) as part of the recall process.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported patient experienced high intraocular pressure post-op day one (1) pressure was 64.Healon gv pro was used during surgery.Surgeon tried to lower the pressure by draining fluid from the anterior chamber by the side incision down to low tonus (tonus muscle tone) according to palpation.1.5-2 hours later another pressure rises, which is why the chamber drained again.In addition, treatment with diamox usually 250 mg 1x2 for 3 days after the pressure increase was detected and any pressure reducing drop.Iopidine or timolol.For 3 days, an increased dose of isopto-maxidex was given 1x6 instead of as otherwise 1x3.Then normalized tonus.The technique the surgeon used in this first case was coaxial irrigation aspiration (i/a) in the anterior chamber (the technique i used for years with no known pressure problems).A total of eight patients were reported, only one patient (this report) of the eight also experienced irritation and synechia.Separate reports are being submitted for each of the additional patients.

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: 9534170
• MDR Text Key: 188718414
• Report Number: 3004750704-2019-00114
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651593
• UDI-Public: (01)05050474651593(17)220831(10)UE31476
• 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
• Remedial Action: Recall
• 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

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: TG85ML
• Device Catalogue Number: 10271514
• Device Lot Number: UE31476
• 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
• Removal/Correction Number: 2020664-12/02/19-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention