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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB ULTRA CONTACT LENSES WITH MOISTURE SEAL TECHNOLOGY

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BAUSCH + LOMB ULTRA CONTACT LENSES WITH MOISTURE SEAL TECHNOLOGY Back to Search Results
Lot Number R62007077
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2017
Event Type  malfunction  
Event Description
I have been wearing bausch + lomb ultra contact lenses for quite some time. Within the last 6 pack box that i ordered from (b)(6), two of the four lenses that i have used so far have ripped in half during regular use. I have the packaging and will send you the lot, serial number, barcodes, etc if you need them.
 
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Brand NameULTRA CONTACT LENSES WITH MOISTURE SEAL TECHNOLOGY
Type of DeviceCONTACT LENSES
Manufacturer (Section D)
BAUSCH + LOMB
MDR Report Key6653093
MDR Text Key78058727
Report NumberMW5070505
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2019
Device Lot NumberR62007077
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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

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