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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
The product has not been returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints in the reported lot number.(b)(4).
 
Event Description
A nurse reported, when implanting the intraocular lens (iol), the lens entered the eye already fractured and had to be extracted.There were no complications or impact to the patient.
 
Manufacturer Narrative
Only the empty lens carton was returned with the packaging inserts.The lens case, lens, and peel pouch were not returned for evaluation.A qualified associated product was indicated.The associated handpiece and viscoelastic were not provided.It is unknown if qualified products were used.The root cause could not be determined for the reported complaint.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key10953608
MDR Text Key220429602
Report Number1119421-2020-01838
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 foreign,health professional
Type of Report Initial,Followup
Report Date 12/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.220
Device Lot Number12747672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MONARCH III D CARTRIDGES, 8065977763, HWV.
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