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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure,he experienced negative dysphotopsia, seeing a sudden dark large spot or shadow, a flash of light at times and floaters.The patient also stated that he did not agree with, because this visually disturbing image or sighting didn¿t look similar to the small floaters i already had before the surgery.Additional information received and stated that, the patient noticed later in the week the visual phenomena in the left eye periphery.A dark shadow and then at times he noticed what he would compare the phenomena to, a contact lens edge and optic in the corner of his eye.There was also the feeling of stitches in the eye area.Lifting both eyelids off the eyeball, the dark shadow would disappear.Or if he raised his hand to the corner of my eye like blinders on a horse the dark shadow would disappear.The patient still wear the special shades over his old glasses in order to not notice the visual phenomena in the periphery area.Additional information received and stated that, the physician further did evaluation like, eye was dilated and the surgeon used the usual slit lamp and then a laser device to possibly see more.The surgeon said she could do a laser surgery for scarring she claims she saw.The patient made an appointment with an ophthalmologist for a second opinion.The second opinion was negative dysphotosia.Additional information received and stated that, another surgeon who on the first visit said he thought i was hit with the visual phenomenon-dysphotopsia.After a few more visits with him he then claims he didn't know what the problem might be.He arranged for me to see a neuro-ophthalmologist.The patient didn't follow up with his arrangement.In another hospital they did surgery and explanted the iol and replaced with another iol during secondary procedure.

• Brand Name: ACRYSOF 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: 14039744
• Report Number: 1119421-2022-00691
• Device Sequence Number: 6301277
• Product Code: HQL
• UDI-Device Identifier: 00380652555760
• UDI-Public: 00380652555760
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 10/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.180
• Device Lot Number: 12759448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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 Age: 67 YR
• Patient Sex: Male