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

Model Number	DFT515
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported following an intraocular lens (iol) implant procedure, the next day during the review surgeon observed that iol broke 25 degrees, so surgeon decided to explant it and implant an another lens.Additional information was requested.
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
Additional information has been received and stated that the lens remained in the programmed location and the next day it already had a 30-degree rotation even though the patient was resting as indicated and upon leaving surgery we left him in the supine position for an hour.We decided to wait for it to subside before rotating it and after 3 weeks the lens was already very fibrous and did not rotate.Surgeon had to cut it and implant an monofocal lens in its place.
Additional Manufacturer Narrative
Additional information provided in b.3., b.5., d.4., d6a., d6b., h.3., h.6., and h.11.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece with a non qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.Information was provided that the lens had rotated 30 degrees one day post op.Surgeon decided to wait 3 weeks before rotating the lens, but by then the lens was very fibrous and would not rotate.Vivity company model(3.00cylinder), 17.5 diopter, (1.5 extended depth of focus) lens was exchanged for an unspecified monofocal lens model.The product has not been received to evaluate.No further information was provided.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).

• 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: 19518034
• Report Number: 1119421-2024-01126
• Device Sequence Number: 8251701
• Product Code: POE
• UDI-Device Identifier: 00380652422413
• UDI-Public: (01)00380652422413(17)260811(11)210813(10)15247759(21)15247759036
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2026
• Device Model Number: DFT515
• Device Lot Number: 15247759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 08/06/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/10/2024; 09/02/2024
• Date Device Manufactured: 08/13/2021
• 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: AMVISC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown