PRESCRIPTION PROGRESSIVE LENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for PRESCRIPTION PROGRESSIVE LENS manufactured by Unk.

Event Text Entries

[136595000] Re: danger of progressive lens. I started wearing prescriptive progressive lens (ppl) for correcting long distance sight. While driving with ppl, particularly at night. I noticed that if i wait at a stop light, and before i proceed, when i turn left to see if traffic is clear, the vision is blurred. Similarly, at times, i have to turn right and see if any pedestrian is approaching. I can't see them! I nearly had a serious accident, when i turned into a regular traffic from a side-street, because i misjudged the ongoing car coming from the left. These vision issues are particularly acute at night (as the strong ambient traffic and city light blurs the traffic). Later i was told progressive lens is only useful for direct sight, and not for peripheral sight. I thought even if the periphery doesn't offer progressive lens effect - there will at least long distance clear vision on the periphery. So wrong! Fda should ban use of progressive lens from being used for driving or other manual operations where side-vision is important. Fda should require all progressive lens ads and claims to include that these could be (1) very dangerous for driving, particularly at night (2) have the periphery filled with long distance vision to see ongoing cars at a distance, and minimize the light distortion. This problems of distorted and blurred images on right and left of the lens went away when i ordered the conventional single lens glasses. I no longer have these issues wearing conventional prescription glasses. When i first ordered the progressive lens, i was told the lens only work for direct sight, but not useful for periphery. They didn't mention the very serious danger in driving. That the periphery was blurred, we could misjudge seriously the danger of a speedy car. Trust fda can work swiftly on this. (b)(6) was retailer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084041
MDR Report Key8337278
Date Received2019-02-12
Date of Report2019-02-11
Date of Event2019-01-30
Date Added to Maude2019-02-13
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 NamePRESCRIPTION PROGRESSIVE LENS
Generic NameLENS, SPECTACLE, NON-CUSTOM PRESCRIPTION
Product CodeHQG
Date Received2019-02-12
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-12

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