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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PINKYPARADISE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

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PINKYPARADISE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problem Corneal Abrasion (1789)
Event Date 10/23/2021
Event Type  Injury  
Event Description
Patient came to our clinic for emergency visit after complications due to wearing contacts that were sold to her without a prescription. The result was a very severe corneal abrasion. Fda safety report id # (b)(4).
 
Event Description
Additional information is added to the report number mw5104966 on 12/20/2021. Mfr unknown.
 
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Brand NamePINKYPARADISE CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
MDR Report Key12703914
MDR Text Key278787918
Report NumberMW5104966
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 10/26/2021 Patient Sequence Number: 1
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