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

Model Number	DFT015
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.A photo was provided showing the lens in the lens case positioned incorrectly.One haptic appears to be broken in the gusset area.We are unable to determine the extent of the damage from the photo.Product history records were reviewed and the documentation indicated the product met release criteria.Based on our observation of the attached photo, the haptic is broken.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.A final root cause cannot be determined based on available information.Additional information was provided that the surgery was successfully completed the follow day.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during surgery, it was found that one of the haptic of the iol broken when opened the wheel, and found separately in the wheel.Also severe damage observed to the edge of optic.Patient left aphakic.Additional information has been requested and received stating that doctor had sent the patient without implanting lens.Four days later, the patient was implanted another lens company monofocal lens was implanted.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the gusset area (not returned).The optic was cracked and had a large portion of lens material missing from the optic edge (not returned).The attached photo in the file appears to be of the returned sample.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The reported lens damage was observed.The observed damage is similar in appearance to handling related damage.The presence of the solution on the returned sample is evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present when opened.Additional information was provided that the surgery was successfully completed the following day.Due diligence has been performed in an attempt to obtain further information on this event.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; 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: 19422577
• Report Number: 1119421-2024-01030
• Device Sequence Number: 18226696
• Product Code: POE
• UDI-Device Identifier: 00380652421348
• UDI-Public: (01)00380652421348(17)280514(11)230517(10)15645859
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/20/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: DFT015
• Device Lot Number: 15645859
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 08/23/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 08/08/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown