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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number ACU0T0
Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
The device and lens were returned in a biohazard bag in the opened carton. The plunger lock and lens stop were removed. The plunger was oriented correctly. Viscoelastic was observed in the device. The plunger was fully advanced. A broken haptic tip was observed smashed on top of the plunger in the nozzle at the wound guard. The round distal tip edge was located on the wrong side of the plunger. No damage was observed to the device. The plunger tip was flexed backward upon return. The lens was separate from the device. The optic was torn (cut) into two pieces and adhered atop each other in dried viscoelastic. One haptic was broken in the gusset area. The distal tip area of the broken haptic was broken, returned inside the device. All product and batch history records are quality reviewed prior to product release. Viscoelastic was not provided. It is unknown if the qualified product was used. The root cause cannot be determined for the reported event. The broken haptic was smashed on top of the plunger and the tip edge was located on the wrong side of the plunger. The trailing haptic position may indicate it was not in a proper position for advancement per the provided diagrams in the instructions for use (ifu). The plunger position in relation to the broken haptic during advancement cannot be determined. The ifu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics. The plunger should be in contact with the trailing optic edge. After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation. Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger. It is unknown if a qualified viscoelastic was used. Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes. The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported that during the intraocular lens (iol) implantation procedure of the left eye, the trailing haptic stuck in the injector. The procedure was completed. Additional information was requested and received indicating that the back haptic was stuck in the injector and the lens tore. There was no patient harm reported.
 
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Brand NameACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key12240392
MDR Text Key263918172
Report Number1119421-2021-01488
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACU0T0
Device Lot Number15117953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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