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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Visual Impairment (2138)
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 has been one other complaint reported in the lot number.(b)(4).
 
Event Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced an unexpected postoperative outcome of -6.00 diopters.The iol was exchanged for another lens with half a diopter less power three weeks following the initial implant procedure.
 
Manufacturer Narrative
Product evaluation: the returned lens is a monofocal single-piece lens.The lens was returned cut into two pieces inside a specimen cup.The specimen cup has been labeled with patient and surgeon information.No product labeling was returned with the sample.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is not in the diopter range; the value falls into the range of 7.5 or 8 diopters higher than what was reported.Product history records were reviewed and documentation indicated the product met release criteria.The most likely root cause was determined to be an inadequate line clearance conducted at cosmetics or lens casing.Based on the analysis of the complaint sample and process review, the scope of the investigation was limited.Nine potential lots were identified.The associated phrs were reviewed and confirmed to have adequate lot reconciliation documentation.This would indicate the lens exchange most likely occurred with a rejected lens due to an inadequate line clearance.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Action taken: a voluntary medical device removal was initiated on (b)(6) 2020.All the non-implanted units from this lot (12726594) were recalled from the market.The fda was notified of this voluntary medical device removal (b)(6) 2020.Two corrective and preventive actions (capas) were identified to address inadequate line clearance and the contributing factor of rejected units left in an optical metrology fixture bin.There are no new complaints for the implanted lenses from this lot, and all non-implanted lenses from this lot has been recovered.Additional information provided in h.7., h.9.And h.10.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of Device
LENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key9514351
MDR Text Key172568954
Report Number1119421-2019-02196
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/08/2020
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 Date06/30/2022
Device Model NumberAU00T0
Device Lot Number12726594
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received02/27/2020
06/23/2020
Supplement Dates FDA Received03/24/2020
07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNSPECIFIED DUOVISC VISCOELASTIC.; UNSPECIFIED DUOVISC VISCOELASTIC
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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