MAGNUM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-29 for MAGNUM * manufactured by Pearle Vision / Cole Vision.

Event Text Entries

[326894] Ordered - as represented and marked as titanium on display frames-well known non allergic-titanium eyeglass frames-received frames 41% titanium+ 61% copper/zinc+4% others. Pt is allergic to certain metals such as copper and zinc in contact with skin. Lenses prescribed by optometrist were trifocal- glasses provided by pearle vision contained only bifocal lenses. Pearle vision, cole vision, cole national were sellers/dispenser and providers of eyeglasses. No quality controls used in dispensing prescription and misrepresentation of materials for frames. Request warning be issued to all re: potential allergic reactions problems with misrepresented frames. Warning to pearl vision/col vision/cole national, 1-not to mislead and misrepresent materials sold, 2-ensure proper filling of prescriptions for lenses. Warning to all users of companies above of potential allergic reaction problems with frames represented and sold previously as titanium which are not substantially that non-allergenic material.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028859
• MDR Report Key: 469528
• Date Received: 2003-06-29
• Date of Report: 2003-06-29
• Date of Event: 2003-04-23
• Date Added to Maude: 2003-07-07
• 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: PATIENT
• 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: MAGNUM
• Generic Name: EYEGLASSES WITH POLYCARBONATE LENSES
• Product Code: HQZ
• Date Received: 2003-06-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 458393
• Manufacturer: PEARLE VISION / COLE VISION
• Manufacturer Address: RT 22 EAST SPRINGFIELD NJ 07081 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-06-29