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 Problem Eye Pain (4467)

Event Date 10/21/2020

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

A research article was published with purpose of we encounter cases of ocular fatigue after cataract surgery.It has been reported that application of 0.05 % cyclopentolate is effective for phakic patients with asthenopia with accommodative spasms.We evaluated the effect of topical 0.05% cyclopentolate on pseudophakic patients with asthenopia.In this retrospective, observational clinical study, patients with asthenopia after cataract surgery, with no known cause other than accommodative spasms were included.There were 6 patients (3 male, 3 female) with 11 eyes.4 eyes had monofocal intraocular lenses (iols), and 7 eyes had multifocal iols.The average age was 68.8 to 5.4.Result of study included the patients started their topical treatment 6.8 sat 3.0 months postoperatively and the evaluation day was 1.7 sat 1.2 months after initiating the treatment on average.All patients had elevated hfc values (68.6 sat 5.0) on the day of treatment initiation and had sign surface candy lower hfc values (58.8 sat 2.4, p< 0.01) on the evaluation day.Four of six patients, all of whom had multifocal iols, experienced relief from subjective symptoms.The study was concluding that topical treatment with 0.05 % cyclopentolate may be effective for asthenopia developing after cataract surgery, especially among patients with multifocal iols.This file belongs to a 66-year-old male patient experienced asthenopia after cataract surgery and iol implantation and was treated with 0.05% cyplegin ophthalmic solution eye drops.The patient was improving on (b)(6) 2020.There are three medical device reports associated with this complaint.This report is 1 of 3.Literature citation: n,k.Et al., effect of topical 0.05% cyclopentolate on asthenopia after cataract surgery.Japanese journal of clinical ophthalmology.2023 sep; 77 (9): 1203-1208.

• 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: 18834782
• MDR Text Key: 336851877
• Report Number: 1119421-2024-00399
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFA200
• Device Lot Number: 12652345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male