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

Model Number SN60WF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140); Ptosis (2620)

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that after intraocular lens (iol) implantation procedure, the distance vision became less clear so much so that the prescription needed to be changed which noticeably clear for distance in the beginning.The consumer mentioned that she used to have only little black lines for floaters, since surgery immediately she was seeing ¿gray clouds¿ floating back and forth with more frequency, along with the original floaters.The floaters sometimes affected vision while driving and night driving was still an issue as the glare from headlights was no better than it was before with or without glasses.Consumer stated that she had drooping of the right eye and it has not gone away, very noticeable to her.Recently she had red at the bottom lid of right eye, doctor prescribed a drop but she did not use as she was afraid to.Consumer additionally mentioned that recently got prescription sunglasses for the first time and seem to be wearing them even when the sun was not shining and when driving.Never had an issue with this before almost like she was sensitive to light, her distance vision was worse when glasses were off as she was able to watch tv in bed and read the guide but it seems more blurry than in the past.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: 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: 16672112
• MDR Text Key: 312586357
• Report Number: 1119421-2023-00575
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655095669
• UDI-Public: 00380655095669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.125
• Device Lot Number: 15205071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female