HEALON GV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-16 for HEALON GV manufactured by Pharmacia & Upjohn Ab.

Event Text Entries

[205678] This report was initially received from a physician at an ambulatory surgical facility requesting info on interactions with healon gv and lidocaine during cataract extraction ( mfr. Report number 9610566-1999-00013). Upon follow-up, the physician provided details for 14 pts. This is the initial report for pt fourteen. Since june, 1999 to present, 14 pt's have developed endophthalmitis (12 sterile) with the use of healon gv and lidocaine. Both products were administered intraocular (not at the same time). Other ophthalmologists have used healon gv and lidocaine retrobulbar with no problems. The clinic has investigated the problem. The same phaco machines and same medications were used. All pt's, within 12 hours post-op, developed clouding and their visual acuity was down to light perception. A vitreous culture was negative. However, an anterior chamber culture was positive. The reporting physician believed this non-sterile endopthalmitis case should be reported since the suspect products could have played a role in the event. The physician believed the interaction to be toxic in nature. Healon gv lot ad58930 was used. This pt was treated with steroids and intravitreal fortaz and vancomycin. He slowly regained their vision. The physician did not feel the event to be life-threatening, however, did believe the event to be sight-threatening and permanent damage to sight if treatment had not been instituted. The reporting physician believes the combination of healon gv, lidocaine, benzalkonium chloride (from various drops), and the acrylic intraocular lenses used by this physician produce a toxic cocktail which leads to the event. When mixed in vitro, the reporting physician indicates the above combination produces a drastic change in ph, which possibly may result in the event. The surgeon has changed to vitrex and regular healon and has not experienced the event further.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610566-1999-00033
MDR Report Key250642
Report Source05
Date Received1999-11-16
Date of Report1999-11-12
Date of Event1999-06-08
Report Date1999-10-21
Date Mfgr Received1999-11-09
Device Manufacturer Date1999-04-01
Date Added to Maude1999-11-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOACHIM VEITH, MD, SR MEDICAL DIR
Manufacturer Street7000 PORTAGE RD
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone6168338777
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEALON GV
Generic NameVISCOLASTIC
Product CodeHQJ
Date Received1999-11-16
Model NumberNA
Catalog NumberNA
Lot NumberAD58930
ID NumberNA
Device Expiration Date2002-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key242825
ManufacturerPHARMACIA & UPJOHN AB
Manufacturer AddressRAPSGATAN 7 UPPSALA SW S-751


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 1999-11-16

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