LUXOTTICA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-30 for LUXOTTICA manufactured by Luxottica Group Spa.

Event Text Entries

[717856] When i was wearing luxottica eyeglasses in 1982, i was involved in a car accident. Something in the right lane in which i was driving caused me to avoid a collision by applying the brakes suddenly and swerving into the left lane of the same highway at the time of the accident. I may have been injured from the accident. In 1981, while i was wearing the same luxottica eyeglasses, dr prescribed for me elavil brand pharmaceutical drug, generic name imipramine. After i took the elavil, i fell asleep while i was sitting at a dining room table waiting for a meal. Now that i do not wear any eye corrective lenses, eyeglasses, spectacles, contacts, or any contact lenses as of 2001, i do not take any psychiatric pharmaceutical drugs anymore, nor do i drive any vehicles anymore. Dates of use: #1. 1981-2001, #2 1981-2006. Diagnosis or reason for use: #1 nearsightedness, mild amblyopia, #2. Emotional sensitivities, event abated after use stopped or dose reduced" #1. Yes, #2 yes. Event reappeared after reintroduction? #1. Yes, #2. Yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5003635
• MDR Report Key: 908352
• Date Received: 2007-08-30
• Date of Report: 2007-08-30
• Date of Event: 1982-01-01
• Date Added to Maude: 2007-09-18
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LUXOTTICA
• Generic Name: EYEGLASSES
• Product Code: HQZ
• Date Received: 2007-08-30
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 887426
• Manufacturer: LUXOTTICA GROUP SPA
• Manufacturer Address: VIA C CANTU 2 MILANO-ITALIA 20123

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2007-08-30