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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN WALDO CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

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UNKNOWN WALDO CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Conjunctivitis (1784); Inflammation (1932); Keratitis (1944); Neovascularization (1978); Visual Impairment (2138)
Event Date 08/07/2020
Event Type  Injury  
Event Description
This patient came in wearing waldo lenses that were never prescribed to her. Her last eye exam was in 2015 and per patient used her glasses prescription to order contacts. The contact lenses have caused reduced vision as they do not appear to be a toric lens which the patients needs. They have also caused corneal neovascularization, papillary conjunctivitis and punctate keratitis. If these contacts were prescribed by an optometrist/ophthalmologist and had routine follow up care these events may have not occurred. Fda safety report id # (b)(4).
 
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Brand NameWALDO CONTACT LENS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
UNKNOWN
MDR Report Key10407448
MDR Text Key203291649
Report NumberMW5096075
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/13/2020 Patient Sequence Number: 1
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