BEUDAMED
    FDA Adverse Event Other Summary report: N

    OK LENS

    MDR report key: 241516 · Received September 20, 1999

    Report

    Report Number
    MW1017201
    Event Type
    Other
    Date Received
    September 20, 1999
    Report Date
    September 7, 1999
    Manufacturer
    UNK
    Product Code
    MUW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF TWO OPTOMETRISTS FOR FALSE ADVERTISEMENT AND INJURIES RELATING TO ORTHOKERATOLOGY USE. APPARENTLY, BOTH OPTOMETRISTS ADVERTISE OR INFORM PTS THAT THEIR OK LENS (NOT CONTEX) ARE SAFE WITHOUT ANY SIDE EFFECTS AND SHOULD BE WORN AT NIGHT. MOREOVER, THEY PROMOTE USAGE ON CHILDREN. A 43-YEAR-OLD LADY SUFFERED CORNEAL ULCER AND SCAR ON LEFT EYE NOW 20/50 CORRECTED. SEVERAL OTHER ADULT PTS HAVE SUFFERED CORNEAL ABRASIONS AND ULCERS BUT ARE WITHOUT SIGNIFICANT RESIDUAL. PT'S CHILDREN ALSO USED THEM BEFORE. DR AND HIS OPTICIAN ADVERTISE ON TV, YELLOW PAGES, NEWSPAPER, AND INTERNET. THEY INFORMED PTS THAT THE OK LENS (NOT CONTEX) ARE PROVEN SAFE AND PTS DO NOT NEED TO WEAR THEM IN THE FUTURE. THEY ARE TO BE WORN AT NIGHT. THEY PROMOTE USAGE ON CHILDREN. A COURT CASE AGAINST DR IS RESOLVED. DR MAY HAVE CHANGED HIS ADVERTISEMENT AND IS NOW ADVERTISING IN TAIWAN AND HONG-KONG. ACCORDING TO RPTR THE PROBLEM IS COMMON IN THE ASIAN COMMUNITY SINCE MOST OF THEM DON'T SPEAK ENGLISH AND USUALLY CAN'T OR DON'T REPORT MISCONDUCT TO AUTHORITIES. SEVERAL OPHTHALMOLOGISTS HAVE INFORMED RPTR ABOUT THEIR PTS SUFFERING FROM CORNEAL ABRASION AND ULCER AS A RESULT OF NON-CONTEX OK LENS. HOWEVER, MOST OF THEM DON'T WANT TO BE INVOLVED. THE FACTS PRESENTED ARE WHAT RPTR PERCEIVED TO BE TRUE AND SHOULD NOT BE CONSTRUED AS EXACT FACTS.

    Description of Event or Problem · 2

    REPORT OF TWO OPTOMETRISTS FOR FALSE ADVERTISEMENT AND INJURIES RELATING TO ORTHOKERATOLOGY USE. APPARENTLY, BOTH OPTOMETRISTS ADVERTISE OR INFORM PTS THAT THEIR OK LENS (NOT CONTEX) ARE SAFE WITHOUT ANY SIDE EFFECTS AND SHOULD BE WORN AT NIGHT. MOREOVER, THEY PROMOTE USAGE ON CHILDREN. AN 11-YEAR-OLD BOY, SUFFERED CORNEAL ULCER AND SCAR ON HIS RIGHT EYE REQUIRING CORNEAL TRANSPLANT. APPARENTLY, EVEN AFTER CORRECTION, HIS RIGHT EYE IS STILL 20/70 WITH A LOT OF ASTIGMATISM. THE PARENTS WERE TOLD THAT THE OK LENS ARE SAFE FOR CHILDREN. DR AND HIS OPTICIAN ADVERTISE ON TV, YELLOW PAGE, NEWSPAPER, AND INTERNET. THEY INFORMED PTS THAT THE OK LENS (NOT CONTEX) ARE PROVEN SAFE AND PT DO NOT NEED TO WEAR THEM IN THE FUTURE. THEY ARE TO BE WORN AT NIGHT. THEY PROMOTE USAGE ON CHILDREN. CASE AGAINST DR IS RESOLVED IN COURT. DR MAY HAVE CHANGED THEIR ADVERTISEMENT AND IS NOW ADVERTISING IN TAIWAN AND HONG-KONG. ACCORDING TO RPTR THE PROBLEM IS COMMON IN THE ASIAN COMMUNITY SINCE MOST OF THEM DON'T SPEAK ENGLISH AND USUALLY CAN'T OR DON'T REPORT MISCONDUCT TO AUTHORITIES. SEVERAL OPHTHALMOLOGISTS HAVE INFORMED RPTR ABOUT THEIR PTS SUFFERING FROM CORNEAL ABRASION AND ULCER AS A RESULT OF NON-CONTEX OK LENS. HOWEVER, MOST OF THEM DON'T WANT TO GET INVOLVED. THE FACTS PRESENTED ARE WHAT RPTR PERCEIVED TO BE TRUE AND SHOULD NOT BE CONSTRUED AS EXACT FACTS.

    Description of Event or Problem · 3

    REPORT OF TWO OPTOMETRISTS FOR FALSE ADVERTISEMENT AND INJURIES RELATING TO ORTHOKERATOLOGY USE. APPARENTLY, BOTH OPTOMETRISTS ADVERTISE OR INFORM PTS THAT THEIR OK LENS (NOT CONTEX) ARE SAFE WITHOUT ANY SIDE EFFECTS AND SHOULD BE WORN AT NIGHT. MOREOVER, THEY PROMOTE USAGE ON CHILDREN. A 19-YEAR-OLD GIRL, SUFFERED RECURRENT INFLAMMATION OF HER EYES. SHE WAS TOLD THAT SHE WOULD NOT NEED TO WEAR ANY LENS IN THE FUTURE AND THAT THE OK LENS WERE SAFE. DR AND HIS OPTICIAN ADVERTISE ON TV, YELLOW PAGE, NEWSPAPER, AND INTERNET. THEY INFORMED PTS THAT THE OK LENS (NOT CONTEX) ARE PROVEN SAFE AND PT DO NOT NEED TO WEAR THEM IN THE FUTURE. THEY ARE TO BE WORN AT NIGHT. THEY PROMOTE USAGE ON CHILDREN. CASE AGAINST DR IS RESOLVED IN COURT. DR MAY HAVE CHANGED THEIR ADVERTISEMENT AND IS NOW ADVERTISING IN TAIWAN AND HONG-KONG. ACCORDING TO RPTR THE PROBLEM IS COMMON IN THE ASIAN, COMMUNITY SINCE MOST OF THEM DON'T SPEAK ENGLISH AND USUALLY CAN'T OR DON'T REPORT MISCONDUCT TO AUTHORITIES. SEVERAL OPTHALMOMOGISTS HAVE INFORMED RPTR ABOUT THEIR PTS SUFFERING FROM CORNEAL ABRASION AND ULCER AS A RESULT OF NON-CONTEX OK LENS. HOWEVER, MOST OF THEM DON'T WANT TO GET INVOLVED. THE FACTS PRESENTED ARE WHAT RPTR PERCEIVED TO BE TRUE AND SHOULD NOT BE CONSTRUED AS EXACT FACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OK LENS ORTHOKERATOLOGY MUW UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other
    2 11 YR Other
    3 19 YR