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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-18 for * manufactured by Alcon Labs.

Event Text Entries

[271206] Pt underwent cataract surgery at ambulatory surgery ctr. After surgery, pt was given standard post-operative kit containing protective eyeglasses, lubricating drops, an eye shield, transpore tape and a bottle of econopred. At the one-day post-op appointment with surgeon, pt stated they didn't know which drops to put in their eye. The dr looked in their post-op kit and found a vial of super glue taped to the box of lubricating tears. The pt had not used anything in the kit and was not harmed, but the potential for eye damage was great. The post-op kits are provided to surgery ctr by alcon laboratories, inc. They are shipped in closed cardboard boxes. Contamination could have occurred either at alcon, at the surgery ctr, at the pt's home, at the dr's office or at some other location where the pt went between their surgery and post-op visit. Rptr is reporting because of the possibility that the super glue may have been put into the kit at alcon labs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1024457
• MDR Report Key: 384164
• Date Received: 2002-03-18
• Date of Report: 2002-03-18
• Date of Event: 2002-03-06
• Date Added to Maude: 2002-03-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: POST-OP KIT/CATARACT SURGERY
• Product Code: HOY
• Date Received: 2002-03-18
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 373211
• Manufacturer: ALCON LABS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-03-18