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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS

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ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS Back to Search Results
Model Number AU00T0
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The manufacturing device history records (dhr) were reviewed and shows that the product met specification prior to release.A product sample has not been received at the manufacturing site.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.The manufacturer internal reference number is: (b)(4).
 
Event Description
A healthcare professional reported that during a cataract procedure, the intraocular lens (iol) unfolded too early while inserting the iol.The surgeon pulled the lens back and replaced the iol.The procedure was completed with an alternate iol.There was no patient harm.
 
Manufacturer Narrative
Additional information has been provided in d.10, h.3, h.6 and h.10.The product was returned for analysis and the reported complaint was not observed.The device was returned loose in the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger and the lens have been advanced into the mid nozzle.The plunger is at the trailing haptic/optic edge - correct position.The leading haptic is looped - acceptable position per directions for use (dfu).No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.The observed looped leading haptic is not a product malfunction.This is an acceptable position per the diagrams provided in the dfu.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
MDR Report Key10532498
MDR Text Key207897498
Report Number9612169-2020-00191
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Model NumberAU00T0
Device Lot Number21263337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/14/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PROVISC VISCOELASTIC; UNSPECIFIED PROVISC OVD, 000451, UNK, BEL
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