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

Model Number	DAT315
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.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).
Event or Problem Description
A materials management reported that approximately after 4 months of implantation of an intraocular lens (iol), explanted intraocular lens due to blurry vision and refractive surprise.The lens was replaced with another lens.Additional information was requested and received stating that lens was replaced with different model with same diopter.Hence the file was considered as non-reportable.Additional information was requested and received stating that, in the surgeon's opinion the lens has the issue.
Additional Manufacturer Narrative
In the initial mdr 2588 (product problem) was incorrectly reported.Corrected information was provided in h.6.Additional information provided in b.2., b.5., h.3.And h.10.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating that lens was replaced with different model with same diopter.Hence the file was considered as non-reportable.

• 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: 15257163
• Report Number: 1119421-2022-01801
• Device Sequence Number: 12430379
• Product Code: POE
• UDI-Device Identifier: 00380652427128
• UDI-Public: 00380652427128
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2025
• Device Model Number: DAT315
• Device Lot Number: 15092786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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: DUOVISC; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; ORA SYSTEM
• Patient Age: 82 YR
• Patient Sex: Female