HEALON GV PRO TG85ML

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for HEALON GV PRO TG85ML manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188724759] Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Date of event: unknown, not provided. If implanted, give date: not applicable, healon gv pro is not an implanted device. If explanted, give date: not applicable, healon gv pro is not an implanted device. (b)(6). (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10


[188724760] It was reported there was an adverse event post cataract surgery due to use of viscoelastic, model healon gv pro, a severe ocular hypertensive crisis occurred. No further information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004750704-2020-00013
MDR Report Key9781405
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-03
Date of Report2020-03-03
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-03
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer StreetRAPSGATAN
Manufacturer CityUPPSALA 751 82
Manufacturer CountrySE
Manufacturer Postal Code751 82
Single Use0
Remedial ActionRC
Previous Use Code0
Removal Correction Number2020664-12/02/19-001-R
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameHEALON GV PRO
Generic NameOVDS
Product CodeLZP
Date Received2020-03-03
Model NumberTG85ML
Catalog NumberTG85ML
Lot NumberUE31283
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-03-03
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-03

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