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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Firing Problem (4011)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: 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. (b)(4).
 
Event Description
A customer reported during an intraocular lens (iol) implant procedure using a preloaded delivery system, the lens would not deploy in the eye. Additional information was requested.
 
Manufacturer Narrative
The device with the lens was returned. The plunger is oriented correctly. Inadequate viscoelastic is observed in the device. The plunger has been advanced under the lens. The lens is advanced to the fill line. The trailing haptic is misfolded under the optic. The optic is misfold. The nozzle was removed and cleaned for further evaluation. The lens was removed during cleaning. Top coat dye stain testing was conducted with acceptable results. Product history records were reviewed and the documentation indicated the product met release criteria. A qualified viscoelastic was indicated. A plunger underride was observed. The root cause may be related to a failure to follow the directions for use (dfu). Inadequate viscoelastic was observed in the device. The dfu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip. This will require approximately 0. 2 ml of viscoelastic. If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens. Plunger underride may occur: ¿ due to rapid advancement faster than the dfu recommended rate. ¿ due to the use of a non-qualified viscoelastic. Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes. If inadequate viscoelastic is placed in the device, this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens. If the device is overfilled with viscoelastic, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding. If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement. Any of the above listed causes alone, or in combination, may create the reported event. Top coat dye stain testing was conducted with acceptable results. The manufacturer internal reference number is: (b)(4).
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7800733
MDR Text Key117852323
Report Number1119421-2018-01169
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
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model NumberAU00T0
Device Lot Number12605290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/21/2018 Patient Sequence Number: 1
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