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

Model Number SA60WF

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

Patient Problems Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced visual disturbance, halos, and streaks in her visual acuity which was noticed three weeks after iol implantation, patient also had yag laser which made worse, in doctor diagnosis it was noticed that patient had a positive dysphotopsia, some of it due to the lens, some of it due to the dings from the laser and some of it from vitreous opacities, the iol was exchanged in a secondary procedure, patient also had pars plana vitrectomy and limbal relaxation incisions.There was no patient harm, the patient¿s issue was resolved and the surgeon prognosis was excellent.The patient was not hospitalized.No further information available.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 15335989
• MDR Text Key: 299064137
• Report Number: 1119421-2022-01887
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652332743
• UDI-Public: 00380652332743
• 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
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.240
• Device Lot Number: 12716629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 82 KG