OPD - SCAN III

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for OPD - SCAN III manufactured by Marco Ophthalmic Inc..

Event Text Entries

[122850547] I requested lens crafters not take any pictures of my eye. They put me in front of a machine and had me look into it, i asked what they were doing, she said measuring eyes and a very intense flash went off. It really affected me immediately. I was very alarmed and uncomfortable. Immediately after flash i experienced eye headache between eyes, glares, extreme sensitivity to light, and anxiety. I complained to assistant and doctor on site, cashiers and eye assistants when trying to purchase glasses. No one took the time out to sit me down and ask me if i needed assistance or water. They all ignored me. They never informed me or prepared me for the extreme flash a blue led light. I believe they purposely did this because i refused cameras before exam started. Affected quality of life, eyes are affected with glasses, eye sensitivity, and eye headaches affects driving and concentration.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5080311
MDR Report Key7929989
Date Received2018-10-02
Date of Report2018-08-28
Date of Event2018-06-08
Date Added to Maude2018-10-03
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 NameOPD - SCAN III
Generic NameRETRACTOMETER, OPHTHALMIC
Product CodeHOX
Date Received2018-10-02
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMARCO OPHTHALMIC INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-02

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