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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB, INC. BIOTRUE ONEDAY DISPOSABLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

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BAUSCH & LOMB, INC. BIOTRUE ONEDAY DISPOSABLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number W67204259
Device Problems Difficult to Open or Remove Packaging Material (2922); Sharp Edges (4013)
Patient Problem Laceration(s) (1946)
Event Date 08/04/2019
Event Type  Injury  
Event Description
I use the bausch & lomb biotrue one day disposable contact lenses. They are packaged in a strip of 5 lenses which the user must separate. After separating them, the foil covering must be peeled back to access the lens. The problem is that the foil edge is extremely sharp at the front corner where it was previously attached to the next lens. Even when being very careful, it is extremely difficult to avoid being cut by the sharp foil edge. I have been cut multiple times; it probably happens every 3rd or 4th lens. B&l should change the packaging to prevent this. Fda safety report id# (b)(4).
 
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Brand NameBIOTRUE ONEDAY DISPOSABLE CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
BAUSCH & LOMB, INC.
MDR Report Key8869415
MDR Text Key153816134
Report NumberMW5088865
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 Patient
Type of Report Initial
Report Date 08/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2020
Device Lot NumberW67204259
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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