MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
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	10/01/2020
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 following a intraocular lens implant procedure 2 years ago, she had blurry vision and diplopia.She approached a specialist and they did muscle surgery on her and corrected the diplopia.However, her vision was still very blurry.She went to another surgeon who did a yag on her which helped some, but there is still a blurry area in her vision.She went to another surgeon who states that something had happened during surgery to cause this and the only way to fix it is to do an iol exchange which they will not do due to the risk of being her other eye is legally blind.She has lost her job due to her vision impairment.Additional information has been requested which states there was no patient harm and no hospitalization required.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated, the product met release criteria.Information was provided that indicated, a qualified cartridge, handpiece, and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.The customer completed questionnaire indicated, that in the surgeon's opinion, the intraocular lens (iol) did not cause or contribute to the event.A procedure occurred post implant, which had helped patient's vision according to the file.The patient has an ocular history with the other eye.At this time, an iol exchange was deemed too risky.As last surgeon decided it will not occur, due to the risk being her other eye is legally blind.If additional information becomes available, the file will be reopened and updated.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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: 15297295
• Report Number: 1119421-2022-01853
• Device Sequence Number: 2710630
• Product Code: HQL
• UDI-Device Identifier: 00380655093139
• UDI-Public: 00380655093139
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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 Expiration Date: 03/05/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.170
• Device Lot Number: 15054212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female