VERILUX PROGRESSIVE LENSES *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-27 for VERILUX PROGRESSIVE LENSES * manufactured by Dr David Geffen.

Event Text Entries

[258003] The glasses pt bought reacted to the rf frequencies that became extremely strong in their house, yard and in the care while the care was running. A 100% ultra violet cover put over the reading glasses stopped the burning of face, cheeks, nose, mouth and chin. It looked like they had become sensitive to the sun. However, the reaction to the rf occurred at night too. The rf transmissions have increased in pt's house this past year. As pt tried to read with these new glasses their face and chest were being "sparked" by the plastic lenses not covered by the rim. The glasses are trifocals with progressive lenses, which are very light. At first pt thought they were dirty so they washed the glasses in water and soap to keep from reacting to them when they put the glasses on. Pt's face would turn red. One morning two mos later pt was out between 9-10 am and had an extremely bad reaction to what they thought was a transmission or the sun. This reaction took a couple of weeks to heal. Pt bought the uv glass covers because it was becoming more difficult to drive. They felt better while driving, working outside the house and sitting at the table while wearing glasses with the uv cover over the glasses. Little by little the skin began to heal and not so red and injured looking. Pt couldn't stop the rf transmissions coming through the house, but the glasses stopped the burning of the skin or "sparking" with the result that the skin turned red and the checks by the rims had a fluid filled appearance. The checks looked shiny. The top part of the glasses were covered by the frame which was "flexon" and did not "spark" on the forehead. The glasses cost $610. 00 and were very attractive and extremely light. Pt tried their other, older glasses and these glasses (also trifocals) responded to the rf frequencies, but much less then the new glasses that within an hr could turn their face red. Not everyone has this type of transmission coming through their house but because pt does and the glasses responded to the rf frequencies and "sparked" causing the skin to be injured pt thought fda should know about it. The glasses pt has been buying since 1991 have been the lightest lenses that was made when they bought the glasses. The last three pairs of glasses have had the lower half uncovered by the rim of the frame, with a plastic thread holding the lens in place. Pt tested the glasses and as the glasses became lighter the reaction to the rf increased with the new pair of glasses responded with the greatest "sparking" that resulted in injury more quickly. The uv cover stopped the "sparking" and injury. While pt was at dr a pair of reading glasses also responded to the rf frequency in pt's house, but only a little. While the rf was occurring pt's ability to read was reduced, something the uv covers would allow. So pt began reading with the uv covers and it was great to be able to read and understand while pt reads. Pt's face improved while they used the uv cover. Right now pt is using one of the pairs of magnifying glasses they bought in a store (around 10 to 15 dollars). They did not "spark" or turn pt's face red or prevent them from reading. The red looked a little like sun burn and was very painful as it increased.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026305
MDR Report Key419459
Date Received2002-09-27
Date of Report2002-09-27
Date of Event2002-04-01
Date Added to Maude2002-10-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVERILUX PROGRESSIVE LENSES
Generic NameFLEXON FRAMES, TRIFOCAL PROGRESSIVE LENSES-VERILUX-WITH ANTI
Product CodeHOI
Date Received2002-09-27
Model Number*
Catalog Number*
Lot Number*
ID NumberPROG V221035VHI, SCRATCH V2750
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key408506
ManufacturerDR DAVID GEFFEN
Manufacturer Address8910 UNIVERSITY CENTER LN SAN DIEGO CA 92122 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-09-27

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