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

Model Number	DFT015
Medical Device Problem Codes	Defective Component (2292); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 physician reported that during implantation of intraocular lens, the trailing haptic stretched.A scratch on the optics were noted after implantation.The lens was retained in eye.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.10.The product was not returned.Two short video clips were provided.The lens and cartridge preparation and initial advancement of the lens were not shown.The first video started with the cartridge tip already inserted into the incision.The lens was visible in the tip.The trailing haptic tip was bent backwards.It was not stretched in the part of the video provided.As the haptic unfolded a scratch was observed on the optic under the trailing haptic tip.The scratch appears to be on the anterior surface.The second video showed the implanted lens in the eye.Two narrow scratches were observed on the anterior surface.Damage of this type can be caused by an instrument used to grasp the lens.The anterior surface does not contact the cartridge lumen during advancement unless the lens is folded incorrectly.A determination for the cause of the scratches cannot be made from the video.It is unknown if there was a loading issue or an issue during the initial advancement of the lens.Information was provided that an unspecified company cartridge and unspecified company injector (handpiece) were used.A non-qualified viscoelastic was indicated.Based on our observation of the video clips, the trailing haptic did not appear stretched, however, the trailing haptic distal tip was bent which may have been interpreted as part of the reported complaint.The optic was scratched.The presence of clinical solution on the lens cannot be determined.It is difficult to make a determination of handling / damage without evaluation of the physical sample.The root cause for the reported complaint may be related to a failure to follow the ifu.A non-qualified viscoelastic was used.The ifu instructs: company foldable iols are qualified for use with a 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 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: 17421595
• Report Number: 1119421-2023-01348
• Device Sequence Number: 9025486
• Product Code: POE
• UDI-Device Identifier: 00380652421263
• UDI-Public: 00380652421263
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Model Number: DFT015
• Device Lot Number: 15351346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/30/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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: HEALON BY JNJ; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Patient Age: 74 YR
• Patient Sex: Male