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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Eye Injury (1845)
Event Date 12/23/2021
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 physician reported that during implantation of an intraocular lens (iol) the lens case was loosen upon open up, lens was not sitting at the correct position.Lens was injected into the eye anterior chamber and found that haptic was missing.The missing haptic could not be found neither in the eye or in the cartridge.Physician decided to enlarge to wound and explanted the lens from the eye and another lens was implanted.Additional information was requested.
 
Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case upon return inside the opened lens carton.Solution was dried on the lens.One haptic was broken in the gusset area.The broken haptic portion was not returned.The other haptic was bent in the gusset area.The lens case was evaluated.The lens case opens and closes securely with no difficulty.No damage was observed to the base or lid.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the complaint as reported.The initial report description indicated that the doctor found iol casing was loosen upon open up, lens was not sitting at the correct position.It is not possible to determine the position of the lens upon customer receipt.Upon sample evaluation, there was no damage observed to the lens case.The lens case opened and closed securely.A broken haptic was observed.The damage was similar in appearance to customer related damage.Due to the presence of surgical solution, and the explanation that the lens was removed from the lens case, loaded into the cartridge, and delivered into the eye, then removed, we are unable to verify that the broken haptic damage was present when opened prior to loading.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
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 Key13307913
MDR Text Key284124299
Report Number1119421-2022-00105
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380655095683
UDI-Public00380655095683
Combination Product (y/n)N
Reporter Country CodeMY
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 Physician
Type of Report Initial
Report Date 03/15/2022
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 Expiration Date02/29/2024
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.135
Device Lot Number12695049
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2021
Initial Date FDA Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR
Patient Outcome(s) Required Intervention;
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