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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during cataract surgery with an intraocular lens (iol) implant procedure, the iol has scratches and it was remained in the eye.Additional information was received stating the lens was explanted and replaced with another lens during initial procedure.There was no patient harm reported.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned posterior surface up instead of anterior in the lens case.Viscoelastic was observed on the lens.The lens was cleaned with klrp (klotho-related protein klrp).The optic had a large crack toward the center (posterior).This was not in the fold path and may indicate a plunger override occurred.Another small crack was observed at the optic/haptic junction (anterior).There is also a scrape mark at the gusset area (anterior).A small crack was also observed to the right of the center crack (anterior).This small crack is similar to damage caused by an instrument used to grasp the lens.The anterior damage may have occurred during the lens removal.A qualified cartridge and viscoelastic were indicated.The handpiece model was not provided.It is unknown if a qualified product was used.The lens had a central crack, which may have been interpreted as the reported scratch.The root cause for the damage cannot be determined.The damage was similar to damage that may occur due to a plunger override/underride.Other damage was observed on the anterior surface, but it cannot be determined if it occurred due to the delivery or the lens removal.The handpiece model was not provided.It is unknown if a qualified product was used.Company foldable 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 the ifu also 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 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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16829068
• Report Number: 1119421-2023-00792
• Device Sequence Number: 1929895
• Product Code: POE
• UDI-Device Identifier: 00380652421645
• UDI-Public: 00380652421645
• 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): 07/24/2023

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 Expiration Date: 08/08/2026
• Device Model Number: DFT315
• Device Lot Number: 15247683
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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: DISCOVISC; MONARCH III, CARTRIDGE D; MONARCH, INJECTOR, UNSPECIFIED
• Patient Age: 65 YR
• Patient Sex: Female