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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number ACU0T0
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other complaints reported in the lot number. Additional information has been requested. (b)(4).
 
Event Description
A customer reported that upon insertion of the intraocular lens (iol) using a preloaded delivery system, the trailing haptic sheared off at the lens/haptic junction. The lens was removed and replaced with a backup lens without incident. Additional information was requested.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8090279
MDR Text Key128196701
Report Number1119421-2018-01633
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberACU0T0
Device Lot Number12613527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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