VISTA EYE CARE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-22 for VISTA EYE CARE * manufactured by Vista Eyecare, Inc..

Event Text Entries

[171333] On 4/99 rptr was diagnosed with a uv sensitive eye condition. Prescription, which clearly calls fo uv protection, was filled at optical dept. After wearing the glasses for 6 months, the eye condition seemed worse so rptr had the uv protection checked to find that it was only 70%, not the legal standard of 95%. Neither store nor vista eye care, the lab that makes the lenses for store, appear interested in the problem. While trying to settle the matter, rptr had the prescription filled at another store, requesting documentation as to the degree of uv protection. When the glasses were sent back to the lab the servies the second store for documentation, rptr was told that the protection was 60%, that it was corrected, and that no documentation was provided since "when you ask for it, you get it. " this was clearly not the case. Rptr states that this industry appears to suffer from a significant lack of quality control, a lack that can have severe consequences to the public. According to rptr the potential for injury to the eye as a result of uv irradiation has been known for a long time. In rptrs case, these dangers are augmentated by a degenerative eye condition that is aggravated by uv light. Many other conditions including cataracts and retinal dystrophies also enhance risk of visual loss from uv exposure. Unfortunately, there are no obvious means of identifying the presence of required/requested uv protection. According to rptr most individuals assume that they did receive what they had requested. Both service a large number of individuals in the us. Rptr hopes that something can be done to protect these individuals from situations such as theirs.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1019175
MDR Report Key283316
Date Received2000-06-22
Date of Report2000-06-21
Date of Event1999-05-01
Date Added to Maude2000-06-28
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 NameVISTA EYE CARE
Generic NameEYE GLASSES
Product CodeHQG
Date Received2000-06-22
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key274164
ManufacturerVISTA EYECARE, INC.
Manufacturer Address296 GRAYSON HWY LAWRENCEVILLE GA 300455793 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-06-22

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