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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT4
Device Problem Output Problem (3005)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/30/2019
Event Type  Injury  
Manufacturer Narrative
A sample device was not 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 reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported that following an intraocular lens (iol) implant procedure, a patient experienced a refractive error.The iol was exchanged for another lens in a secondary procedure.Additional information has been requested.
 
Manufacturer Narrative
The lens was returned inside a glass specimen jar filled with a clear water like solution.One haptic is broken in the gusset area (returned).The optic is cut into two portions, typical of insertion and removal.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ TORIC SINGLEPIECE IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key8368596
MDR Text Key137118648
Report Number1119421-2019-00227
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Model NumberSN6AT4
Device Catalogue NumberSN6AT4.170
Device Lot Number12302401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Initial Date Manufacturer Received 01/30/2019
Initial Date FDA Received02/25/2019
Supplement Dates Manufacturer Received10/13/2019
Supplement Dates FDA Received11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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