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

Model Number	SN6AT5
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implantation, the surgeon noticed a scratch on the lens.The scratch was not seen before folding and was in a location that was not touched during the folding process.The lens remained implanted, as the scratch was peripheral.There are three medical device reports associated with this report.This is 1 of 3.Additional information has been requested.
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens or company model combination used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The account indicated the product was not available to evaluate.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21771892
• Report Number: 1119421-2025-00915
• Device Sequence Number: 12811921
• Product Code: MJP
• UDI-Device Identifier: 00380652250993
• UDI-Public: (01)00380652250993(17)280801(11)230804(10)15690382
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.200
• Device Lot Number: 15690382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 08/04/2023
• 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 , CARTRIDGE D; MONARCH III IOL, INJECTOR; SYNERGY OVD
• Patient Age: 84 YR
• Patient Sex: Male