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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUCLID SYSTEMS CORPORATION EUCLID MAX ORTHOKERATOLOGY CONTACT LENS; LENS, CONTACT (RIGID GAS PERMEABLE), EXTENDED WEAR

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EUCLID SYSTEMS CORPORATION EUCLID MAX ORTHOKERATOLOGY CONTACT LENS; LENS, CONTACT (RIGID GAS PERMEABLE), EXTENDED WEAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796)
Event Date 10/01/2022
Event Type  Injury  
Event Description
Euclid max orthokeratology lens caused corneal ulcer and abrasion on right eye.Optometrist advised i discontinue orthokeratology for rest of (b)(6) 2022.Bausch + lomb.
 
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Brand Name
EUCLID MAX ORTHOKERATOLOGY CONTACT LENS
Type of Device
LENS, CONTACT (RIGID GAS PERMEABLE), EXTENDED WEAR
Manufacturer (Section D)
EUCLID SYSTEMS CORPORATION
MDR Report Key16043570
MDR Text Key306277328
Report NumberMW5113998
Device Sequence Number1
Product Code MWL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/22/2022
Patient Sequence Number1
Treatment
ACCUTANE; FISH OIL; VITAMIN D
Patient Outcome(s) Disability;
Patient Age28 YR
Patient SexMale
Patient Weight109 KG
Patient EthnicityNon Hispanic
Patient RaceAsian
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