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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT8
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Edema (1791); Hyphema (1911); Inflammation (1932); Intraocular Pressure Increased (1937); Itching Sensation (1943); Blurred Vision (2137); Visual Impairment (2138); Dizziness (2194)
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: (b)(4).
 
Event Description
A facility representative reported that, following intraocular lens implant procedure, the patent was unable to see and was feeling dizzy. The lens was exchanged in a secondary procedure. Additional information was received that, 1 day post op patient had ocular itching. Vision was very blurry and foggy. Due to increased inflammation difluprednate qday drop started until next appointment. 1 week post-op, the patient was having mild corneal bullous change superior which may be causing some visual blurring - will be discontinuing difluprednate as it may be increasing iop and corneal edema. Mild corneal bullous change superior are improved since stopping difluprednate. Iop is improved but borderline od s/p hydrus -inferior microphyphema continued - not much change compared to prior visit. Developed hyphema. Continue prednisolone qid and taper weekly. The lens was exchanged and patient is doing well post-operatively.
 
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Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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 Key14699056
MDR Text Key294281654
Report Number1119421-2022-01285
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652278058
UDI-Public00380652278058
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Model NumberSN6AT8
Device Catalogue NumberSN6AT8U210
Device Lot Number12543095
Was Device Available for Evaluation? No
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/15/2022 Patient Sequence Number: 1
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