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	Blurred Vision (2137)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision.The lens was exchanged for another lens model following the initial procedure.Clinical reason for explant was mentioned as mechanical complication and there was no patient harm.Additional information was received and the lens was replaced with another lens model 02 days following the initial procedure.
Additional Manufacturer Narrative
The lens was returned inside a plastic specimen jar with a screw top lid.Solution was dried on the lens.The lens was cleaned with klotho-related protein (klrp) to evaluate.No damage was observed to the lens.Power and resolution were verified by an engineering technician.The lens met specification for power and resolution.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a non-qualified cartridge and non-qualified viscoelastic.The handpiece indicated is qualified for use with this lens when used with a qualified combination.The root cause cannot be determined for the reported complaint.The returned lens was undamaged.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 power and resolution were verified by an engineering technician.The lens met specification for power and resolution for an company model 26.0 diopter lens.Information was provided that the monofocal company model 26.0 diopter lens was removed and replaced with a non-alcon monofocal of the same diopter (26.0).This information may suggest that the replacement lens was an improved selection for this patient's vision needs.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; 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: 19296906
• Report Number: 1119421-2024-00919
• Device Sequence Number: 5920181
• Product Code: HQL
• UDI-Device Identifier: 00380652555920
• UDI-Public: 00380652555920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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.260
• Device Lot Number: 15650705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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 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: 71 YR
• Patient Sex: Male