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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 Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported creases on an implanted intraocular lens (iol).There is currently no reported patient impact.Additional information was requested.
 
Manufacturer Narrative
Additional information provided in h.3., h.6., and h.10.The product was not returned.All product and batch history records are quality reviewed prior to product release.The provided photos were reviewed.Two photos were provided.The photos show the lens in the eye.Two marks are observed.The marks are not in the fold path.The marks are oriented to the right of the center of the optic.The marks are not straight and are slightly curved in opposite directions.The indicated marks are not similar to any type of marks previously observed on delivered lenses.These marks may be related to a handling technique at the site.A qualified cartridge was indicated.The handpiece information was not provided.It is unknown if a qualified handpiece was used.A non-qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported marks.Based on review of provided photos, the indicated marks are not similar to typical loading or delivery damage.Two photos were provided for this file.Two marks are observed.The marks are not in the fold path.The marks are oriented to the right of the center of the optic.The marks are not straight and slightly curve in opposite directions.These marks may have been cause by an instrument or technique at the facility.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 Key10417490
MDR Text Key203819361
Report Number1119421-2020-01156
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 10/14/2020
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 Expiration Date03/31/2024
Device Model NumberSN60WF
Device Catalogue NumberSN60WFC205
Device Lot Number12708813
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/04/2020
Initial Date FDA Received08/17/2020
Supplement Dates Manufacturer Received10/12/2020
Supplement Dates FDA Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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