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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 Problem Material Integrity Problem (2978)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event Description
A health professional reported that during an intraocular lens (iol) implant surgery, the lens presented with a straight leading haptic.The lens sank into the vitreous after insertion into the eye.Additional information has been requested.
 
Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the dfu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the company aspheric intraocular lens with company preloaded delivery system dfu, only qualified company 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 for the company aspheric intraocular lens with company preloaded delivery system and is not recommended under any circumstance.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Event Description
New information received from the customer stating the surgery was completed after exchanging the lens.
 
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Brand Name
ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
Type of Device
LENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key8353962
MDR Text Key136645915
Report Number1119421-2019-00189
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 foreign,other
Type of Report Initial,Followup,Followup
Report Date 04/12/2019
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? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Model NumberACU0T0
Device Lot Number12594511
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/06/2019
Initial Date FDA Received02/20/2019
Supplement Dates Manufacturer Received02/21/2019
04/11/2019
Supplement Dates FDA Received02/26/2019
04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
Z-HYALIN
Patient Outcome(s) Other;
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