MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. 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	Headache (1880); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received from the health authority and reported following an intraocular lens (iol) implant procedure, the patient experienced hypersensitive to light both indoor lighting and especially sunlight.The patient experienced these after her cataract surgery in 2022.When the patient was outdoors, she wears sunglasses fitted by an optician with wide temples and they do not help.In (b)(6) 2026, she visited an optician and according to the doctor there was nothing wrong with her eyes.After spending time outdoors, her eyes became extremely strained and afterward she had difficulty focusing on vision.The areas around her eyes become red and swollen and her eyes look tired and overworked.She becomes very fatigued and develops headaches, she cannot stay outdoors on a sunny day and becomes extremely tired.Patient feels that her life was limited by light sensitive eyes.Before the cataract surgery, she did not have these problems.Additional information was received and stated, patient was informed that the light sensitivity would improve after 6 weeks of surgery.However, she had experienced light sensitivity ever since and it was difficult to be outdoors in sunlight and dazzled by indoor lighting.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: AcrySof IQ Natural Singlepiece IOL
• Common Device Name: Intraocular Lens
• Manufacturer (Section D): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50234569
• Report Number: 9612169-2026-01852
• Device Sequence Number: 13327415
• Product Code: HQL
• UDI-Device Identifier: 00380655093207
• UDI-Public: (01)00380655093207(17)260912(11)210914(10)25267524
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 09/12/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 25267524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 09/14/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 198 LB