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

Model Number	SN6AT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, explanted iol for reason mechanical defect.The iol was exchanged for same model and diopter lens 1 months 21 days following the initial implant procedure.Additional information has been received stating patient's issues were resolved and the surgeon¿s prognosis was good.
Additional Manufacturer Narrative
Correction information provided in d.4.Additional information was provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The product investigation could not identify a root cause for the reported unspecified complaint of "mechanical defect." information was provided that the company (3.00cyl), 20.0 diopter lens was replaced with a company (3.00cyl), 22.5 diopter lens.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Additional information was provided that the patient had pre-existing epiretinal membranes erm/macular pucker.No additional information has been provided at this time.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to requests for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned wrapped in white gauze material placed into a small brown envelope.Viscoelastic was dried on the lens.One haptic was broken in the gusset area and not returned.The optic was cut into pieces, typical of an insertion and removal.One optic portion was cracked near the edge.The other optic portion was scratched from the center toward the optic edge on the anterior surface.The posterior optic was cracked near the edge.Each lens is subjected to a 100 percentage assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.A retest of the power and resolution could not be conducted due to the lens damage.Product history records were reviewed, and the documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause cannot be determined for the reported complaint of "explant: mechanical defect".More information has been requested for clarification.The lens was returned cut into pieces, typical of an insertion and removal.Additional optic and haptic damage was observed.Each lens is subjected to a 100 percentage assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.A retest of the power and resolution could not be conducted due to the lens damage.Information was provided that the company lens (3.00cyl), 20.0 diopter lens was replaced with a company lens (3.00cyl), 22.5 diopter lens.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Additional information was provided that the patient had pre-existing erm/macular pucker.No additional information has been provided at this time.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5., h.3., h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating blurred vision as reason for explant.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, 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 Key: 19613497
• Report Number: 1119421-2024-01213
• Device Sequence Number: 6974273
• Product Code: MJP
• UDI-Device Identifier: 00380652250993
• UDI-Public: (01)00380652250993(17)250513(11)200514(10)15070912(21)15070912061
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 05/13/2025
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.200
• Device Lot Number: 15070912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 11/15/2024; 01/09/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/17/2024; 12/12/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• 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: ACRYSOF IQ TORIC SINGLEPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female