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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following the intraocular implantation of (iol) lens there was capsular tear.The procedure was not completed.Additional information has received that patient harm includes posterior capsular bag tear.Additional information has received that cause of tear was unknown as per surgeon.Patient was still left aphakic.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the distal tip area (not returned).The optic is broken with a large piece of loose lens material.There are several areas where the optic is torn\split\cracked.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a non-qualified cartridge.The file indicates the use of a handpiece and viscoelastic that is approved to be used with a qualified lens and company delivery system combination.We are unable to verify the reported event.Information in the file states the cause of tear is unknown per surgeon.Lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has received that the iol was removed during the initial procedure.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: 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 Key: 17815664
• Report Number: 1119421-2023-01656
• Device Sequence Number: 2480381
• Product Code: HQL
• UDI-Device Identifier: 00380655095805
• UDI-Public: 00380655095805
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.300
• Device Lot Number: 12739812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II LOADING FORCEPS; MONARCH III INJECTOR; MONARCH III CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown