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U.S. Department of Health and Human Services

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

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ALCON LABORATORIES, INC. ACRYSOF®; INTRAOCULAR LENS Back to Search Results
Model Number SN6AT4
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
Intraocular lens bent in packaging from manufacturer.Manufacturer response for iol, (brand not provided) (per site reporter).They took down description of the problem, removed the lens from consignment & issued a returned goods authorization number.
 
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Brand Name
ACRYSOF®
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES, INC.
6201 south freeway
fort worth TX 76134
MDR Report Key13522882
MDR Text Key285542958
Report Number13522882
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 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberSN6AT4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/29/2021
Event Location Hospital
Date Report to Manufacturer02/14/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23725 DA
Patient SexFemale
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