GOLDMANN APPLANATION *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-24 for GOLDMANN APPLANATION * manufactured by Haag-steit Usa Inc..

Event Text Entries

[4247163] During the intraocular pressure test, the goldmann applanation tonometer measuring prism tip was applied to bilateral eyes to assess the intraocular pressures. Following this assay, the patient began to complain of discomfort and blurred vision in both eyes. After an examination of the patient's eye, it was determined the patient sustained circumferential cornea irritations, which lined up directly with the tonometer measuring prism tip used in the intraocular pressure test. Upon review of the event and examination of the equipment, it was noted that the tonometer measuring prism tip used on the patient and several other tonometer tips appear to have cracking and erosion of the applanation tip which comes in contact with the eye. The staff has been cleaning the tips with the manufacturer's recommended cleaners (sodium hydrochlorite and hydrogen peroxide), yet the tips continue to be damaged during the cleaning process. Due this event and the quantity of damaged tonometer measuring prisms, despite following the manufacturer's cleaning instructions, we are now using disposable measuring prisms.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3702842
• MDR Report Key: 3702842
• Date Received: 2014-03-24
• Date of Report: 2014-03-24
• Date of Event: 2014-02-06
• Report Date: 2014-03-24
• Date Reported to FDA: 2014-03-24
• Date Reported to Mfgr: 2014-03-27
• Date Added to Maude: 2014-03-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GOLDMANN APPLANATION
• Generic Name: TONOMETER, MANUAL
• Product Code: HKY
• Date Received: 2014-03-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HAAG-STEIT USA INC.
• Manufacturer Address: 3535 KINGS MILLS ROAD MASON OH 45040 US 45040

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-24