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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SA60AT
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been one other complaint reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported an intraocular lens (iol), "was warped when placed in the eye".The procedure was completed the same day.Additional information was requested.
 
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Brand Name
ACRYSOF SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key9425844
MDR Text Key176058916
Report Number1119421-2019-02068
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/06/2019
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 Operator Health Professional
Device Expiration Date05/31/2024
Device Model NumberSA60AT
Device Catalogue NumberSA60AT.200
Device Lot Number12718198
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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