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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 Problems Device Damaged by Another Device (2915); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Four samples were returned.Twenty samples were not returned.There were 19 cases with a method code of device not returned, a results code of no findings available, and a conclusion code of cause not established.There was one case with a method code of testing of actual/suspected device, a results code of operational problem identified, and a conclusion code of cause not established.There were two cases with a method code of testing of actual/suspected device, a results code of operational problem identified, and a conclusion code of cause cannot be traced to device.There was one case with a method code of device not returned, a results code of operational problem identified, and a conclusion code of cause not established.(b)(4).
 
Event Description
This report summarizes 24 malfunction reports of preloaded intraocular lens (iol) delivery system damaging another device.The reported patient ages are unknown.There were six male patients, and 18 unknown gender.
 
Manufacturer Narrative
Additional information provided in h.10.One file received additional information making it no longer reportable and will be removed from the summary of this report.No additional information will be submitted for this single file.The manufacturer internal reference number is: (b)(4).
 
Event Description
This report summarizes 22 malfunction reports of defective intraocular lenses (iols).
 
Manufacturer Narrative
One file received additional information making it no longer reportable and will be removed from the summary of this report.No additional information will be submitted for this single file.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 Key10335162
MDR Text Key201875859
Report Number1119421-2020-01067
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported24
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 01/28/2021
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 Operator Health Professional
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.XXX
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/01/2020
Initial Date FDA Received07/28/2020
Supplement Dates Manufacturer Received10/01/2020
01/01/2021
Supplement Dates FDA Received10/28/2020
01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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