Instructions for Completing the MedWatch Voluntary Reporting Form (3500) for adverse events involving decorative contact lenses. This same information can be provided for all contact lens related adverse events.
This form can be found at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
Please provide the following information if available:
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In B.5 write on the form the diagnosis prefaced by the association with decorative lenses such as “DECORATIVE CONTACT LENS RELATED-Corneal Ulcer” and then describe details of the adverse event including information, such as:
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In B.6, please report culture results if taken, indicating the organism isolated
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In B.7, please provide prior ocular history or relevant systemic history (e.g., diabetes, immunosuppression, auto-immune disease, other infectious problems, eating disorder, depression, and other mental health issues), topical steroid or topical anesthetic use. Social history such as tobacco use, alcohol, and recreational drugs, etc.
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In E section, write from the lens label or from the patient’s report
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From the label:
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Enter the brand of the contact lens if known
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Enter the name and address of the manufacturer of the contact lens
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Lot number if available
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