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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Endophthalmitis (1835)
Event Date 03/16/2024
Event Type  Injury  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced endophthalmitis during second follow up visit.The patient was treated immediately and successfully.The patient was fine and still for follow up and observation.There are five medical device reports associated with this complaint.This report is 5 of 5.Additional information has been received stating patient required intravitreal injection of antibiotics.Latest visual acuity was reported as 20/32.
 
Manufacturer Narrative
Correction information provided in d10.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key19124336
MDR Text Key340372759
Report Number1119421-2024-00730
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380655093184
UDI-Public00380655093184
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/17/2024
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? No
Device Operator Health Professional
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.195
Device Lot Number15674696
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/19/2024
Initial Date FDA Received04/17/2024
Supplement Dates Manufacturer Received04/18/2024
Supplement Dates FDA Received05/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BSS STERILE IRRIGATING SOLUTION.
Patient Outcome(s) Required Intervention; Other;
Patient Age74 YR
Patient SexFemale
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