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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

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ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problem Structural Problem (2506)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2019
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and 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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported that when the intraocular lens (iol) was placed in the injector, the lens curled up.There was no patient contact and the procedure was completed the same day.
 
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Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
Manufacturer (Section G)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI   00000
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8605951
MDR Text Key144965080
Report Number9612169-2019-00099
Device Sequence Number1
Product Code HQL
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 Nurse
Type of Report Initial
Report Date 05/13/2019
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 NumberSN60WF
Device Catalogue NumberSN60WF.170
Device Lot Number21209761
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2019
Initial Date FDA Received05/13/2019
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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