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

Model Number	DFT015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that after lens was introduced, it came with defective/broken haptics.The patient also had rupture of the posterior capsule with vitreous loss.
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.The reported "broken haptic" complaint was not observed.Both haptics area attached and undamaged.The optic was cut from edge past center, typical of insertion and removal.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of qualified viscoelastics.The associated cartridge and delivery system/handpiece was not provided.It is unknown if qualified products were used.Other lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The reported "rupture of the posterior capsule with vitreous loss" could not be confirmed.Replacement lens information was not provided.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: 16059611
• Report Number: 1119421-2022-02751
• Device Sequence Number: 6382484
• Product Code: POE
• UDI-Device Identifier: 00380652421195
• UDI-Public: 00380652421195
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2026
• Device Model Number: DFT015
• Device Lot Number: 15274216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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: CENTURION ACTIVE SENTRYHAND PC; PROVISC OVD; VISCOAT OVD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown