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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS

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ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT3
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Dizziness (2194)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. 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 an intraocular lens (iol) implant procedure, the patient was feeling like it wasn't right, toric was too strong (dizzy). The iol was exchanged for a different iol 1 month after initial implantation. Additional information has been requested.
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information was provided by the surgical coordinator, indicating that the patient experienced blurry vision and the outcome of the event has resolved with treatment.
 
Manufacturer Narrative
Evaluation summary: the product was returned for analysis and the reported complaint could not observed. Additional observations were as follows: iol returned in a specimen container. Solution is dried on both surfaces of the optic and haptics. The optic is torn/split-cut and scratched/marked-rejectable. The optic has two perpendicular torn/split-cuts, resulting in approximately one quarter of the optic being removed and returned. Optical power & resolution could not be verified due to the extensive optic damage. We are unable to determine the root cause for the reported complaint. The manufacturer internal reference number is: (b)(4).
 
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Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7285956
MDR Text Key100570077
Report Number9612169-2018-00030
Device Sequence Number1
Product Code MJP
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
Type of Report Initial,Followup,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.200
Device Lot Number21196258
Other Device ID Number00380652249898
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
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