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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ACRYSOF ULTRASERT; INTRAOCULAR LENS

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ALCON LABORATORIES, INC. ACRYSOF ULTRASERT; INTRAOCULAR LENS Back to Search Results
Model Number AU00T0
Device Problems Activation, Positioning or Separation Problem (2906); Scratched Material (3020)
Patient Problem Insufficient Information (4580)
Event Date 05/19/2021
Event Type  malfunction  
Event Description
Events: 1-alcon lens for case did not deploy properly; 2-second alcon lens was implanted but under microscope the surgeon noted the lens was scratched.
 
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Brand Name
ACRYSOF ULTRASERT
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES, INC.
6201 south freeway
fort worth TX 76134
MDR Report Key12187742
MDR Text Key262186397
Report Number12187742
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAU00T0
Device Catalogue NumberAU00T0V25.5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2021
Event Location Hospital
Date Report to Manufacturer07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age27375 DA
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