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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BAUSCH AND LOMB ULTRA FOR PRESBYOPIA LENSES, SOFT CONTACT, DAILY WEAR

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BAUSCH & LOMB INCORPORATED BAUSCH AND LOMB ULTRA FOR PRESBYOPIA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Corneal Infiltrates (2231)
Event Date 12/17/2021
Event Type  Injury  
Event Description
Corneal infiltrate and corneal hypoesthesia secondary to soft contact lens overwear. Fda safety report id# (b)(4).
 
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Brand NameBAUSCH AND LOMB ULTRA FOR PRESBYOPIA
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
MDR Report Key13059805
MDR Text Key282633818
Report NumberMW5106193
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
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/20/2021 Patient Sequence Number: 1
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