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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SA6AT5
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Code Available (3191)
Event Date 11/20/2018
Event Type  Injury  
Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information was requested and received.(b)(4).
 
Event Description
A facility representative reported that one month following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens model and power.The reason given was wrong power for the patient.The representative reported there was no enlarged incision or sutures required.
 
Manufacturer Narrative
Product evaluation: the lens was returned in a piece of surgical gauze.Solution is dried on the lens.The lens was cut in half.The optic has a small split coming from the gusset area.The optic is also split for the optic edge towards the center of the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.The lens was returned cut in half.A power/resolution test could not be performed due to the lens being cut in half.Product history records were reviewed and the documentation indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key8196296
MDR Text Key131402757
Report Number1119421-2018-01795
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 03/18/2019
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 Date05/31/2022
Device Model NumberSA6AT5
Device Lot Number12548163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received02/21/2019
Supplement Dates FDA Received03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMVISC PLUS; AMVISC PLUS
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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