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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SA60WF
Device Problem Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.A sample product was not returned for analysis.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported a scratched intraocular lens (iol).There was patient contact but no patient harm reported.The procedure was completed the same day.Additional information requested.
 
Manufacturer Narrative
Additional information provided in a.1, a.2, a.3, and b.5.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information received states the lens was loaded improperly.
 
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Brand Name
ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key10325963
MDR Text Key201905712
Report Number1119421-2020-01057
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/05/2020
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 Model NumberSA60WF
Device Catalogue NumberSA60WF.195
Device Lot Number12724268
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/13/2020
Initial Date FDA Received07/27/2020
Supplement Dates Manufacturer Received07/17/2020
Supplement Dates FDA Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
D CARTRIDGE; DUOVISC
Patient Age71 YR
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