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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Before production release, each device history record is reviewed to ensure that the product met the required specifications and release criteria.A non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint.The file indicates the use of a qualified cartridge and viscoelastic.Information regarding the handpiece was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The product was not returned for evaluation.It is unknown if a qualified products combination was used.The file indicates the reason for explant was due to an intraoperative complication.The company lens 21.0 diopter lens was replaced with company, 21.0 diopter lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, after implantation of the company¿s 21.0 d intraocular lens, a capsular rupture occurred.It was explanted the same day and replaced with a 3-piece company 21.0 d lens.There was no further impact on the patient.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned taped to the exterior of the fully assembled lens case on the posterior surface inside the opened peel pouch that was placed into the lens carton.The optic edge was torn and cracked toward the optic center.Another optic area was cracked on the anterior optic surface near the edge.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications.A qualified cartridge and viscoelastic were used.The handpiece information was not provided.It is unknown if a qualified handpiece was used.The product investigation could not determine the root cause for the reported complaint of "capsular rupture-it must be explanted".The lens was torn and cracked from the edge toward the optic center, typical in appearance to damage from insertion and removal.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The file indicates the reason for explant was due to an intraoperative complication.The company lens 21.0 diopter lens was removed and replaced with a multipiece company lens 21.0 diopter lens model.No additional information has been provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23579905
• Report Number: 1119421-2025-02963
• Device Sequence Number: 9577877
• Product Code: HQL
• UDI-Device Identifier: 00380652555821
• UDI-Public: (01)00380652555821(17)300419(11)250421(10)16030878
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.210
• Device Lot Number: 16030878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 04/21/2025
• 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 MULTIPIECE IOL.; MONARCH III IOL CARTRIDGE C.; VISCOAT OVD.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown