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 Number: 9610566-1999-00033
• MDR Report Key: 250642
• Report Source: 05
• Date Received: 1999-11-16
• Date of Report: 1999-11-12
• Date of Event: 1999-06-08
• Report Date: 1999-10-21
• Date Mfgr Received: 1999-11-09
• Device Manufacturer Date: 1999-04-01
• Date Added to Maude: 1999-11-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JOACHIM VEITH, MD, SR MEDICAL DIR
• Manufacturer Street: 7000 PORTAGE RD
• Manufacturer City: KALAMAZOO MI 49001
• Manufacturer Country: US
• Manufacturer Postal: 49001
• Manufacturer Phone: 6168338777
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEALON GV
• Generic Name: VISCOLASTIC
• Product Code: HQJ
• Date Received: 1999-11-16
• Model Number: NA
• Catalog Number: NA
• Lot Number: AD58930
• ID Number: NA
• Device Expiration Date: 2002-03-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 242825
• Manufacturer: PHARMACIA & UPJOHN AB
• Manufacturer Address: RAPSGATAN 7 UPPSALA SW S-751

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	1999-11-16