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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 Device Contamination with Chemical or Other Material (2944)
Patient Problems Glaucoma (1875); Blurred Vision (2137)
Event Date 06/06/2022
Event Type  Injury  
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: 2022-54441.
 
Event Description
A patient reported that there was a surgery to replace the lens.The surgery was difficult, and it took 40 minutes.Following the iol implant procedure, the patient's intraocular pressure (iop) sometimes raises to 30, black flies swim in the eye around the luminous objects of the areola.A preliminary diagnosis was glaucoma.Additional information received and stated that, the patient has foggy vision.The suture was placed during the surgery but the patient was not known the reason for suture.
 
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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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key15474677
MDR Text Key300552510
Report Number9612169-2022-00486
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380655095683
UDI-Public00380655095683
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/23/2022
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? No
Device Operator Health Professional
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.135
Device Lot Number21285190
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/29/2022
Initial Date FDA Received09/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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