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

Model Number	DFT015
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, when injecting the lens into the eye, it was noticed that the lens had a crack in the middle of the optics.The iol was explanted during initial procedure.Additional information has been requested, received and stated there was no patient harm and the patient is in postoperative recovery from phaco surgery and normal.
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).
Additional Manufacturer Narrative
Additional information provided in d.10., h.3., h.6.And h.10.The sample was not returned.A photo was available in the file.The lens was shown placed back into the lens case base.Solution appears to be dried on the lens.One haptic is bent in the gusset and distal area due to the replacing position in the lens case.The optic was cracked or split from optic edge to optic center.The optic edge was pressed against a post of the lens case.Information was provided that indicated the use of a qualified cartridge and viscoelastic.An unspecified company handpiece was indicated.It is unknown if the qualified handpiece was used.The root cause for the reported complaint cannot be determined.Based on our observation of the attached photo, the optic appeared to be cracked or torn.Clinical solution appears to be present on the lens.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.An unspecified company handpiece was indicated with the qualified lens/cartridge/viscoelastic combination.It is unknown if a qualified company handpiece was used.The ifu instructs: 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.It is unknown if an appropriate amount of viscoelastic was used in the qualified cartridge.The ifu instructs: 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.Follow up attempts have been made.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is bent around a post in the lens case with a portion of the distal tip cut off.The optic is split from the edge across the center of the lens.No crack is observed but it is possible it was split along the same area the crack was seen.The returned lens matches the provided photo(s).Information was provided that indicated the use of a qualified cartridge and viscoelastic.An unspecified company handpiece was indicated.It is unknown if the qualified handpiece was used.Lens damage was observed.The reported crack may have been in the same area where the lens is split.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.An unspecified company handpiece was indicated with the qualified lens/cartridge/viscoelastic combination.It is unknown if a qualified company handpiece was used.The ifu instructs: company foldable iols are qualified for use with company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that 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.It is unknown if an appropriate amount of viscoelastic was used in the qualified cartridge.The ifu instructs: 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 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; 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: 17996589
• Report Number: 1119421-2023-01812
• Device Sequence Number: 6670082
• Product Code: POE
• UDI-Device Identifier: 00380652421300
• UDI-Public: 00380652421300
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 09/08/2026
• Device Model Number: DFT015
• Device Lot Number: 15265337
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 01/08/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/27/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; DISCOVISC OVD; MONARCH III CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL, CARTRIDGE C; MONARCH IOL DELIVERY SYSTEM; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Patient Sex: Male