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

Model Number	DFT615
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 surgeon reported that during an intraocular lens (iol) implant procedure, the lower haptic of iol was damaged after implantation.The lens was left in side the eye.The surgeon was planned to explant the lens.Additional information has been received and stated that, the iol was explanted in secondary procedure.As per the surgeons opinion, the introducer damaged the lens because the lens was a toric lens and thicker than normal.The recommended cartridge could have helped prior to the surgery to prevent the damage to the lens.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6., and h.10.The lens was returned in a small specimen jar.Solution was dried on the lens.The optic was cut into four jagged portions.The portions had additional small cracked areas and splintering damage from the line of cut damage.One optic portion included a fully intact haptic.The other haptic was broken (possibly cut) in the distal area and not returned.The account indicated the use of a qualified associated cartridge and handpiece.A non-qualified viscoelastic was indicated.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was indicated.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.Company recommends using the qualified company delivery system or any other company qualified combination.The file indicated that the lens was left in the eye as the lower haptic was damaged but not broken.Updated information indicated that the lens was explanted days later on april 24, 2023.The lower portion of both haptics are undamaged, and the distal area of one haptic was broken or cut.Information was provided that indicated in the surgeon's opinion: "the introducer damaged the lens because the lens was a toric lens and thicker than normal.The recommended cartridge could have helped prior to the surgery to prevent the damage to the lens." however, a qualified company cartridge was indicated as the cartridge used in this event.The diopter of this lens is at the top of the qualified range for use in a company cartridge when used with a qualified viscoelastic and handpiece.The use of the non-qualified viscoelastic in the qualified cartridge is the most likely root cause for the reported damage.The optic damage is typical in appearance to damage created when removing a lens from the eye.A measurement of the returned lens' thickness overall could not be conducted due to the lens was cut into four jagged pieces with additional damage.Upon return, the explanted lens was found to be cut into four jagged portions.One optic portion contained a fully intact, undamaged haptic.Another optic portion contained a haptic that appeared to have been cut in the distal area, as only the gusset area of the haptic was attached to the optic.The removed haptic was not returned.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: 16972501
• Report Number: 1119421-2023-00919
• Device Sequence Number: 15063647
• Product Code: POE
• UDI-Device Identifier: 00380652423380
• UDI-Public: 00380652423380
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: DFT615
• Device Lot Number: 15346901
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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 INJECTOR; MONARCH III CARTRIDGE D; OPTHEIS BIO 3%
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male