MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, patient found that the vision was not as good as expected, only poor near vision.The lens had to be explanted and found a scratch on the lens.The lens was scratched when inserting into the cartridge in initial procedure.The lens was exchanged for another lens 01 month 18 days following the initial procedure.Additional information was received and stated, scratch was noticed during the follow-up examinations.
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 lens was returned in a self-seal pouch.Viscoelastic was observed on the lens.The lens had been cut into two pieces across the center.The pieces were returned adhered to each other.The lens was cleaned with klotho-related protein (klrp) for further evaluation.A scratch was observed on the anterior surface near the optic edge.The scratch was perpendicular to the travel path.This was a narrow scratch, which was similar to damage caused by forceps.Small scratches were also observed on the anterior surface at one gusset area.A chipped areas was also observed on the edge bedside the cut area.A qualified cartridge was indicated with a non-qualified viscoelastic.It is unknown if a qualified handpiece was used.The root cause for the reported scratch may be related to a failure to follow the instruction for use (ifu).A non-qualified viscoelastic was indicated.The observed scratch was on the anterior surface perpendicular to the travel path.This damage was similar to damage cause by loading forceps.The narrow scratch did not appear to be in the visual field.The ifu instructs: company foldable intra ocular lens (iols) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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.Information was provided that the lens was implanted (b)(6) 2024.The patient complained only about their near vision.Upon review on 07-nov-2024 the scratch was observed.The company lens (1.50cyl), 22.5 diopter lens was exchanged for a company (1.50cyl), 23.0 diopter lens.The exchange for the same model lens with a change in diopter would indicate the company, 23.0 diopter was an improved selection for the patient¿s near vision.The reporter did not wish to be contacted further.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION 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: 21130026
• Report Number: 1119421-2025-00138
• Device Sequence Number: 18008605
• Product Code: POE
• UDI-Device Identifier: 00380652421690
• UDI-Public: (01)00380652421690(17)280620(11)230623(10)15670207
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFT315
• Device Lot Number: 15670207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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: EYEFILL C - VSO.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; PE-HA-VISCO - VSO.; UNSPECIFIED INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female