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

Model Number	DAT415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Capsular Bag Tear (2639)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional that following implantation of an intraocular lens (iol) the capsule rupture, does not know if the lens caused the rupture.It was a very small eye, the capsule appeared intact upon implanting the lens, then wrinkled and the lens started to go to the vitreous.He was able to remove the lens and replace it with a 3-piece lens.Additional information received and stated that, rent in capsule resulting in changing from a vivity to a monofocal lens.The patient also required postop eyedrops because of the tear in the capsule.Patient was left with residual astigmatism.Patient's postop visual acuity is 20/25 at his last visit.The patient right eye is a lazy eye and he relies more on his left eye.He was sent to his referring optometrist to get glasses as needed to correct his remaining astigmatism.The surgeon¿s prognosis was good, but may need glasses now for astigmatism and near vision.
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
Additional information provided in h.3., h.6., and h.10.Information was provided that a non-qualified company cartridge was used.The diopter of this lens model was beyond the range that was qualified for use in a company specified cartridge.The lens is qualified for use in a company specified cartridge.A qualified company handpiece was indicated and a non-qualified viscoelastic.The surgeon provided information that he does not know if the iol caused the rupture.It was a very small eye, the capsule appeared intact upon implanting the lens, then wrinkled and the lens started to go to the vitreous.The surgeon was able to remove the lens and replace it with a 3-piece non-company lens.Also, a non-qualified cartridge and non-qualified viscoelastic were used with this lens.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.Company recommends using the qualified company delivery system or any other company qualified combination.The manufacturer internal reference number is: 2022-82812.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING 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: 16186517
• Report Number: 1119421-2023-00117
• Device Sequence Number: 14121408
• Product Code: POE
• UDI-Device Identifier: 00380652428033
• UDI-Public: 00380652428033
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: 06/21/2026
• Device Model Number: DAT415
• Device Lot Number: 15221352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: AMVISC PLUS; B&L LENS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male