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

Model Number	DFT015
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during cataract and intraocular lens (iol) implant procedure, before folding, the lens was visually inspected which was in flawless condition and subsequently implanted.After implantation, a groove appeared on the periphery of the lens which was located outside the optical part.As per reporter, the malfunction occurred in the phase of lens implantation.The patient has not been affected by the malfunction so far.The surgeon decided not to explant the lens.The procedure was completed on the same day.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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.A photo was provided.The photo showed a single-piece lens in the eye.An area to the left side was circled in blue.A narrow line/shadow was visible on the left side of the optic.Unable to determine from the photo, if this is a scratch or a fold line.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was not returned.A photo as provided.The photo showed a single-piece lens in the eye.An area to the left side was circled in blue.A narrow line/shadow was visible on the left side of the optic.Unable to determine from the photo, if this is a scratch or a fold line.Product history records were reviewed, and documentation indicated the product met release criteria.A qualified cartridge and viscoelastic were used with a non-qualified handpiece.Only a photo of the lens inside the eye was provided to review.A narrow line/shadow was visible on the left side of the optic.The root cause is most likely related to a failure to follow the instructions for use (ifu).A non-qualified handpiece was used.The ifu instructs: company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a 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: 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.File will be reopened if new information is received.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: 21604789
• Report Number: 1119421-2025-00684
• Device Sequence Number: 15670623
• Product Code: POE
• UDI-Device Identifier: 00380652421270
• UDI-Public: (01)00380652421270(17)280804(11)230807(10)15695133
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 15695133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 08/07/2023
• 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: DUCKWORTH AND KENT DK7797-2, LOT 0056; MONARCH III IOL , CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 61 YR
• Patient Sex: Female