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

Model Number ASKU

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

Patient Problem Capsular Bag Tear (2639)

Event Date 03/01/2024

Event Type  Injury  

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 Description

The study was conducted to assess the visual function and reading performance with acrysof iq vivity (toric and non-toric) iol vs.Standard monofocal acrysof iq (toric and non-toric) iol in a randomized comparative study.Randomized, prospective, single-center, controlled trial.Randomization will be performed using an online randomization system that indicate which patient receives which iol.Sixty-eight patients were included.Fourteen patients were excluded due to loss to follow-up, withdrawn consent, surgery complication and device malfunction.The study was concluded with very good visual acuity for distance (4m), intermediate (at 66cm superior to aspheric monofocal) and even near vision (at 40cm superior to aspheric monofocal) for vivity group.High patient satisfaction among the vivity group (qov and aston halometer similar to aspheric monofocal group).Fixation duration significantly shorter in vivity group at 66cm, but just moderately better in reading speed or number of fixation.This file belongs to a patient who had capsule rupture during the surgery.Study citation: oliver findl et al., reading performance with a non-diffractive enhanced depth of field (edof) iol: a randomized controlled trial., vienna institute for research in ocular surgery; hanusch-krankenhaus department of opthamology, vieena, austria.

• Brand Name: ACRYSOF 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: 18993021
• MDR Text Key: 338883529
• Report Number: 1119421-2024-00574
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other