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

Model Number	MN60AC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	06/18/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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 or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure the patient experienced pain all the time.Additional information has been requested and received stating since having cataract surgery oculus sinister (os) in 2014, patient has had nothing but trouble in the left eye.Has had eye pain starting the day after surgery.Patient asked the surgeon why eye hurts and surgeon said did not know.Patient sought a second opinion and was told intraocular lens (iol) was placed behind the iris because the capsular bag had ruptured during cataract surgery.Patient has since had a corneal transplant descemet membrane endothelial keratoplasty (dmek) in (b)(6) 2020.She takes the following eye drops to manage and treat her pain: nonsteroidal anti-inflammatory drug (nsaid) once daily, corticosteroid once daily, lubricant/artificial tear four times daily, osmotic agent twice a day all in os only.She called company to find out if it was safe for her to have a magnetic resonance imaging (mri) with the iol.Patient was recommended to undergo mri to rule out trigeminal nerve issues.The patient wanted the eye to be removed.All day, every day patient was taking care of it trying to stay ahead of the pain.
Additional Manufacturer Narrative
Correction information was provided in h.6.(on initial mdr the evaluation code of b17 was submitted.It should have been b20 on the original mdr).Additional information was provided in d.3.And h.11.The lens remains implanted.The reporter was the patient.The reporter indicated the surgery was in 2014.They stated a pc-tear occurred during surgery and the company lens was implanted behind the iris.Patient contacted company to enquire about mri (magnetic resonance imaging) safety with the iol.The company lens is safe for mri.The reporter provided information about issues with their eye since the initial surgery.It is unclear if the issues are related to the eye, the lens placement or both.The file will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21035192
• Report Number: 1119421-2024-02644
• Device Sequence Number: 21127366
• Product Code: HQL
• UDI-Device Identifier: 00380655095140
• UDI-Public: (01)00380655095140(17)150731(11)100901(10)11060079
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.215
• Device Lot Number: 11060079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 09/01/2010
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female