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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 Problems Physical Resistance (2578); Malposition of Device (2616)
Patient Problems Eye Injury (1845); Rupture (2208)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested and received.(b)(4).
 
Event Description
A surgeon reported that during an intraocular lens (iol) implant procedure, there was plunger resistance and when additional force was given the lens shot into the eye rupturing the posterior capsule.The lens was implanted into the sulcus outside the capsular bag.Additional information was requested.
 
Manufacturer Narrative
The product was not returned for evaluation.The provided video was reviewed by qa and r&d.The device preparation was not shown.The device tip comes into view and is inserted into the incision.The lens is rapidly advanced from out of view (mid-nozzle) into the eye.It can be observed that the plunger has overridden the optic.There is a jump as the lens is advanced into the eye.The lens is positioned with an instrument.Slight edge damage is observed where the plunger advanced over the optic.A large piece of loose matter is observed floating onto the anterior optic surface as the eye is filled with solution.The video ends.The lens remains implanted.No intervention shown.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.Based on review of the provided video the root cause for the reported events appears to be related to a failure to follow the dfu.The lens was advanced from mid-nozzle directly into the eye.The lens was not inspected at the fill line as directed.A plunger override was plainly visible as the lens was advanced.This should have been detected at the inspection step and use of the device discontinued.The observed "jump" into the eye was due to the override and the speed of the delivery.In addition, a non-qualified viscoelastic was indicated.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu and is not recommended under any circumstance.(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, 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 Key7510519
MDR Text Key108135813
Report Number1119421-2018-00593
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/24/2018
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? Yes
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Model NumberAU00T0
Device Lot Number12481865
Other Device ID Number00380652381932
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received05/17/2018
Supplement Dates FDA Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OPEGAN HI OVD
Patient Outcome(s) Other;
Patient Age93 YR
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