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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 SN6AT4
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Eye Injury (1845)
Event Date 03/30/2022
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 has been two other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A procedure manager reported that, during intraocular lens (iol) implant procedure, the incision was enlarged slightly and inserted into the eye, whilst injecting the iol into the eye the trailing haptic was torn from the optic. The surgeon then cut the iol out and asked for the backup lens. The surgeon asked for a cartridge and a blunt probe to push the iol down the cartridge and into the eye. Unfortunately, during insertion of the iol, the posterior capsule ruptured and an anterior vitrectomy was performed the procedure was completed and the patient was left without a lens implant with a view to return for a secondary lens implant at a later date. Additional information was requested.
 
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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 Key14336660
MDR Text Key291207578
Report Number1119421-2022-00974
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652250603
UDI-Public00380652250603
Combination Product (y/n)N
Reporter Country CodeUK
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberSN6AT4
Device Catalogue NumberSN6AT4.290
Device Lot Number15278237
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
Treatment
B&L INJECTOR; HEALONID; MONARCH III IOL CARTRIDGE C
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