MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that after intraocular lens iol) implantation, she had the impression that something was wrong with the implanted lens - depending on which side the artificial light fell from, she could see a bar of light, as if the light was refracted on some element of the lens.She reported the matter to the doctor and the decision was made to rotate the lens by 90 degrees angle.After that she could see the bar of light slightly shifted from the previous lens position.She reported that she did not have such symptoms during the day; this only applied to artificial lighting.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The product was not returned.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Associated product 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 was not returned.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
According to the additional information received after final report submission, the primary procedure was done on (b)(6) 2023.Consumer had first symptoms appear on (b)(6) 2023, which she reported at her first follow-up visit on (b)(6) 2023.The surgery was done in left eye.She had deterioration of vision in her left eye and white streaks and flashes kept appearing.Thus, it was decided to rotate the lens.The lens rotation procedure was done on (b)(6) 2024.She reported that her left eye was always weaker than the right since childhood.She even wore glasses but without visible effects.She does not have any particular eye disease.
Additional Manufacturer Narrative
Product history records were reviewed, and the documentation indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE 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: 19212183
• Report Number: 1119421-2024-00816
• Device Sequence Number: 18169132
• Product Code: HQL
• UDI-Device Identifier: 00380652332644
• UDI-Public: (01)00380652332644(17)271009(11)221011(10)15504649
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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 Model Number: SA60WF
• Device Catalogue Number: SA60WF.190
• Device Lot Number: 15504649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 08/28/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/18/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female