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

Model Number TG85ML

Device Problem Contamination (1120)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2019.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the post-op visit of patients operated in july using healon gv pro causes early secondary cataracts in 80 percentage of cases.Reportedly additional information indicates that ovd is difficult to remove at the end of the procedure and causes white debris between the lens and the capsule.Surgeon does not know where the debris are from.This leads to pre and post-operative inconvenience.Reportedly customer states patients might need a yag procedure, doctor told about 25/10 after seeing many of post-op patients.Yag is going to have to be planned.No further information provided.

Manufacturer Narrative

Section h6: conclusion code 4316 is provided as complaint is related to a field action.Section h9: 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.

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 (b)(4) and (b)(4).

• 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: 9379935
• MDR Text Key: 168769639
• Report Number: 3004750704-2019-00086
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)220531(10)UE31364
• 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,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: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: TG85ML
• Device Catalogue Number: UE31364
• Device Lot Number: UE31364
• 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): Other