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

Model Number	DFT015
Medical Device Problem Codes	Material Twisted/Bent (2981); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, scratch was detected on the haptic of the lens, lens was cut and removed from the eye during initial procedure.The procedure was completed with another lens.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
Fda product code (a0415) has been updated to (a040609).The lens was returned in the lens case.Viscoelastic was observed on the lens.The lens had been cut into two pieces, returned adhered to each other with viscoelastic.One haptic was broken-gusset area returned in the cartridge.The remaining haptic was not damaged.The used company cartridge was returned.Viscoelastic was observed in the cartridge.A broken haptic was observed in the cartridge tip.The used company cartridge was cleaned for further evaluation.The haptic was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results.The haptic has a narrow scratch distal area.It is unclear how this was visible with the haptic still in the cartridge.The intended complaint may have been the broken haptic.A qualified cartridge was used.It is unknown if a qualified handpiece and viscoelastic were used.The root cause for the reported "scratched haptic" could not be determined.A broken haptic was returned inside a cartridge.The haptic had a narrow scratch distal area.The intended complaint may have been the broken haptic.The orientation of the haptic in the cartridge pointed toward the loading area, would indicate it was not positioned properly for advancement.The cartridge tip had a large aneurysm on the bottom left side.Heavy stress was also observed.This would indicate the lens/plunger were not in acceptable positions for advancement.Topcoat dye stain testing was conducted with acceptable results.The instructions for use (ifu) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the opthalmic viscoelastic device (ovd)-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 22738319
• Report Number: 1119421-2025-02176
• Device Sequence Number: 7198331
• Product Code: POE
• UDI-Device Identifier: 00380652421270
• UDI-Public: (01)00380652421270(17)280808(11)230811(10)15698214
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: DFT015
• Device Catalogue Number: DFT015.220
• Device Lot Number: 15698214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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
• Patient Sex: Unknown