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); Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non healthcare professional reported that one of the haptics was broke during an intraocular lens (iol) implantation.The patient was extremely demanding and unfortunately didn't met the expectations.In the post-surgical examinations it was found that the iol was decentralized and that it will be necessary to perform the replacement.Additional information has been requested.
Additional Manufacturer Narrative
On initial mdr the event outcome mentioned as reportable malfunction an error.It should have been other medically significant event original mdr.On initial mdr the concomitant products company cartridge and unspecified ovd reported as an error.A qualified cartridge was used.The handpiece and viscoelastic information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The product has not returned.It is unknown if a qualified handpiece and viscoelastic were used.The ifu (instruction for use) 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that during implantation the capsular bag was ruptured.

• 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: 17690197
• Report Number: 1119421-2023-01564
• Device Sequence Number: 6512810
• Product Code: POE
• UDI-Device Identifier: 00380652421218
• UDI-Public: 00380652421218
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2026
• Device Model Number: DFT015
• Device Lot Number: 15240274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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: CARTRIDGE D.; MONARCH IOL INJECTOR.; UNSPECIFIED OVD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male