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

Model Number	DFT015
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Blurred Vision (2137); Capsular Bag Tear (2639); Insufficient Information (4580)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that, following intraocular lens implant procedure, the iol was explanted due to medical reasons.
Event or Problem Description
Additional information was received from the hcp indicating that the patient experienced an iol drop caused or contributed by a posterior capsule gap.The patient also experienced reduced visual acuity.The iol was exchanged for another lens model one week following the initial implant procedure.It was reported the patient was hospitalized as a result of the event.The patient¿s issues have resolved following the secondary procedure.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from the hcp that during iol implantation, a small corner of haptic broke off which eventually caused the posterior capsule rupture.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Information indicated a company handpiece was used, however it stated a company cartridge was not used.A non- company viscoelastic was indicated.The reported damaged haptic may be related to a failure to follow the instructions for use (ifu).Information indicated a company handpiece was used, however it stated a monarch cartridge was not used.The ifu instructs that a 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 foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.Original information stated the lens was replaced due to a medical issue.Further information was provided that the company lens was replaced with an anterior chamber iol due to an iol dislocation related to a posterior capsule gap.Upon further request for information it was indicated "small corner of haptic broke off during implantation which eventually caused the posterior capsule rupture".There have been no other complaints reported in the lot number.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: 14831434
• Report Number: 1119421-2022-01389
• Device Sequence Number: 19424929
• Product Code: POE
• UDI-Device Identifier: 00380652421218
• UDI-Public: 00380652421218
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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 Expiration Date: 07/28/2026
• Device Model Number: DFT015
• Device Lot Number: 15240271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 08/15/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/28/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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: MONARCH INJECTOR, UNSPECIFIED.; NON COMPANY CARTRIDGE.; VERISYS.; Z-CELCOAT.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female