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 Corneal Abrasion (1789); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137)

Event Date 01/17/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned.All product and batch history records are quality reviewed prior to product release.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that following implantation of an intraocular lens (iol) the patient experienced foreign body sensation (fbs) and was rubbing eye excessively.Caused a corneal abrasion and healed after few weeks.Blurry vision, blood shoot eye and dry eye.The patient was prescribed with restasis.His bcva improved from 20/400 before surgery to 20/40 after surgery.The surgeon has diagnosed dry eye with treatment.Pcp to investigate possible allergic reaction.Additional information was received.

• 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 ; 8175514979
• MDR Report Key: 12335305
• MDR Text Key: 267022069
• Report Number: 1119421-2021-01578
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: 00380655093160
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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.185
• Device Lot Number: 15100546
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AVASTIN; CENTURION VISION SYSTEM; DUOVISC VISCOELASTIC SYSTEM; EYLEA; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; RESTASIS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR