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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 Ejection Problem (4009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
The lens and the qualified company cartridge were returned inside the opened lens carton along with the disassembled lens case. Insufficient viscoelastic was observed in the cartridge. Stress lines were observed at the tip. The cartridge has evidence of being placed into a handpiece. The lens was returned in a small clear bag. Small bits of solution was dried on the lens. No damage was observed to the lens. The lens was cleaned for further evaluation. A dimensional inspection (plan view) was conducted. The lens was within the specification per the approved template. The cartridge was cleaned for further evaluation. Top coat dye stain test was conducted with acceptable results. Product history records were reviewed and documentation indicated the product met release criteria. A non-qualified viscoelastic was indicated. The root cause of the reported complaint may be related to a failure to follow the ifu. A non-qualified viscoelastic was indicated. The ifu instructs that an company qualified delivery system and viscoelastic combination should be used. The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process. Company recommends using the qualified company iol delivery system or any other company qualified combination. An inadequate amount of viscoelastic was observed in the cartridge. The ifu also instructs to completely fill the cartridge with ovd(ophthalmic viscosurgical devices) (diagram provided) immediately prior to loading and delivery of the lens. Do not attempt to load the lens without adequate ovd in the device. Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage. Top coat dye stain test was conducted with acceptable results. ` the manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse unit manager reported that the lens was early out of the cartridge at the level of the main incision with patient contact. 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
8175514979
MDR Report Key12470755
MDR Text Key271369508
Report Number1119421-2021-01748
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652250498
UDI-Public00380652250498
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN6AT4
Device Catalogue NumberSN6AT4.235
Device Lot Number15116910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
Treatment
MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH IIIC CARTRIDGE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OVD
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