HEALON GV PRO TG85ML 10270514

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 2020-03-30 for HEALON GV PRO TG85ML 10270514 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188352732] Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. If implanted; give date: n/a (not applicable). Healon is not an implantable device. If explanted; give date: n/a (not applicable). Healon is not an implantable device; therefore, not explanted. Last name: unknown, information not provided. (b)(6). (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.
Patient Sequence No: 1, Text Type: N, H10


[188352733] It was reported that during the injection of the healon gv pro, the surgeon noted the product was difficult to expel and that it clogged the hand piece. The surgeon reported of acute and chronic post operation hypertonia leading to abnormalities, postop refraction corneal burn, deformed pupil, intraocular pressure (iop) increases, lens dislocation, swelling of the capsular bag leading to post refraction anomalies, blindness in a case of glaucoma patient and hypertonia requiring an early yttrium-aluminum garnet (yag) treatments. Reportedly, about one hundred (100) patients are affected. Symptoms were treated. No additional information was provided. This report captures the event for few patients with cataract surgery who had pain overnight with an increase of iop over 40/45 mm/hg. Drops were administrated and showed minor decrease of the iop. In one specific case, the iop persisted for around 2 weeks post op , which consequently resulted in iris atrophy-necrosis is mid dilatation. Quarter of the iris is necrosed and the patient outcomes is fine. Iris does not move. Additionally, the customer provided two different lot numbers. Due the limited information available to date, it was not possible to obtain the batch number related to this specific case. This report will pertains to the healon gv pro, lot number ue3128. A separate report will be submitted on the lot number ue31098.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004750704-2020-00029
MDR Report Key9901543
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2019-12-05
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2020-03-30
Model NumberTG85ML
Catalog Number10270514
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 Received2020-03-30
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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