HDV1 LENSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for HDV1 LENSES manufactured by Carl Zeiss.

Event Text Entries

[92656055] It seems as though vendor carl zeiss designs hdv, hdvi, drivesafe, now the new one is energizeme lenses of 30ty something. As spin off from the 40ty something lenses, what lenses do are over prescribed that which the optometrist prescribes. I started to wearing them as (b)(4) decided to sell this product. It was to my suspicion to know that anything other than what the doctor prescribes is not to be done. Carl zeiss vision boldly presents these energizeme groups of lenses which really goes too far. It is bifocals not prescribed by optometrist to pt in writing at all and to say the least a. 75 and some optician give to children. I have seen one child came in with complaints of headaches at his annual eye exam which the doctor removed that bifocal. Knowing carl zeiss is a foreign market vendor "why is it foreign market vendors walk in this country with their set of rules to cash in on people. " "why is it that other vendors agree to vendor conduct of what a doctor must do. " if the doctor does not write the script out as they do for glasses it should not be given. Is this not fraud. It is not customer service here, it is being accountable to the profession. I cannot wear my glasses i purchased from (b)(6) due to getting migraines on my off day and going to a neurologist to counteract them and (b)(6) caught on to my ways and followed up with firing me with excuses they cannot take an accountability on. After all, i am the top person in that location i worked in. The other part is hemp, if hemp is illegal (b)(6) and other places in (b)(6) mall has been selling it for at least 15 years as the rope product in beauty aides. Physicians formula as a hemp based product to it, oh, do not tell me it is a wrinkle reducer. I am working with a neurologist right now and being fired, i have no migraine at present. I am not wearing my (b)(6) glasses that have an over prescribing factor to them. To undo the full effect of 5 years of wear is still to be determined. Questioning others with migraines and working in neurologist. If, not permanent damage. Date the person started taking or using the product: (b)(6) 2013. Date the person stopped taking or using the product: (b)(6) 2017. Reason for use: to see with my eyes. "is the product compounded: yes, did the problem stop after the person reduced the dose or stopped taking or using the product: yes. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073252
MDR Report Key7024607
Date Received2017-11-13
Date of Report2017-11-07
Date of Event2013-06-12
Date Added to Maude2017-11-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHDV1 LENSES
Generic NameHDV1 LENSES
Product CodeHQG
Date Received2017-11-13
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-13

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