• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BIO TRUE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAUSCH & LOMB INCORPORATED BIO TRUE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
Contact lens with black flecks when i opened the package. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIO TRUE CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
MDR Report Key12828953
MDR Text Key280955980
Report NumberMW5105377
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

-
-