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	Macular Edema (1822); Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and 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 non health care professional reported that following an intraocular lens (iol) implant procedure, the patient was looking at the eye chart and saw a hazy spot that does not move, it also seemed as though, she was looking through a mesh net and vision is not as clear.Additional information received and stated that, the patient had swelling in macula and doctor had prescribed two week course of steroids.Still the patient swelling did not resolved and the other symptoms might be because of swelling of macula.
Event or Problem Description
Additional information received from the patient and stated that, the patient had in the beginning both eyes were noticeably clear for distance, and then as time went on the distance vision became less clear so much so that the prescription needed to be changed, she was told the original one would not change.The patient used to have only little black lines for floaters, since surgery immediately she was seeing what patient will call ¿gray clouds¿ floating back and forth with more frequency, along with the original floaters she had.So much so they sometimes affect her vision while driving.Night driving is still an issue the glare from headlights is no better than it was before with or without glasses.The left eye vision was blurry even after prescribing more drops.The patient was referred to another doctor who found her macula was swollen and needed an injection and that cleared up by the next day.The patient recently got prescription sunglasses for the first time and she seem to be wearing them even when the sun is not shining when she was driving.Never had an issue with this before almost like she was sensitive to light.The patient also noticed in the last month it seems as though her distance vision when glasses are off is worse, she used to be able to watch tv in bed and read the guide but it seems more blurry than in the past.Glare at night and distance vision were her major two complaints.Additional information received form the consumer and stated that, surgeon said that, she had scar tissue that will be fixed with laser off next month hopeful that will help and also gave me a different eye drop that help make the pupil smaller to help with the light issues.Additional information received form the consumer and stated that, patient visited a doctor and doctor gave another lens to try and consumer used it the next morning and holy heck it was horrible, instantly got the brow headache.The surgeon mentioned could happen and had to immediately use liquid tears to lessen the amount in my eyes.The patient have been researching different lenses that could help with issue since the patient had green eyes.It appears to be an issue with those of us who have green or blue eyes.Do you have a lens that my doctor could replace, doctor didn't seem to think that a replacement lens was a good idea but patient suffering here with light sensitivity and gray clouds floating by.They told me that those were there before the cataract was taken out and now that the new lens was put in it is allowing more light in and thus the floaters and clouds are more noticeable.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information provided in a.2., b.5., and h.6.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: 15318240
• Report Number: 1119421-2022-01863
• Device Sequence Number: 5230250
• Product Code: HQL
• UDI-Device Identifier: 00380655095652
• UDI-Public: 00380655095652
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: SN60WF
• Device Catalogue Number: SN60WF.120
• Device Lot Number: 15378489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 Age: 66 YR
• Patient Sex: Female