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

Model Number	DFT015
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2025
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 the intraocular lens (iol)implantation surgery, the material was found to be defective.
Additional Manufacturer Narrative
Additional information was provided in b.3., d.9., h.3., h.6.And h.11.The lens was returned loose in bag with the lens case lid.Viscoelastic was dried on both sides of the lens.The lens was cleaned with klrp for further evaluation.The optic has a scrape mark on the anterior surface.A short, narrow scratch was observed on the anterior surface near the optic/haptic junction.There was a similar scratch in the same area on the posterior surface.A cracked area was observed near the edge on the posterior surface.Parallel damage (scratches) were observed on both surfaces.This damage was caused by an instrument used to grasp the lens across the center.The lens dimensions (plan view) were acceptable using an approved template.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 defined in the device master record were met.Associated products were not provided.It is unknown if qualified associated products were used.The root cause for the reported "material defect" could not be determined.A material defect was not observed.The retuned lens was damaged.The damage may have been the intended complaint.The lens was returned loose in a bag.Viscoelastic was dried on both sides of the lens, which would suggest it was loaded in a cartridge.Short narrow scratches were observed near one optic/haptic junction (posterior and anterior surface).This damage was similar to damage caused by forceps.A cracked area was observed on the posterior surface near the edge.This may indicate a plunger underride occurred.A scrape mark was observed on the anterior optic surface.This damage may have may have occurred during return due to the lens being loose in a bag with the lens case lid.It is unknown if qualified associated products were used.The instructions for use (ifu) instructs: company foldable intra ocular lens (iol)s 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.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The 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 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 plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.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: 23681410
• Report Number: 1119421-2025-03057
• Device Sequence Number: 9846472
• Product Code: POE
• UDI-Device Identifier: 00380652421270
• UDI-Public: (01)00380652421270(17)290407(11)240409(10)15838940
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 15838940
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Patient Sex: Unknown