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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137)
Date of Event	01/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12335305
• Report Number: 1119421-2021-01578
• Device Sequence Number: 2826238
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: 00380655093160
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 09/20/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.185
• Device Lot Number: 15100546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVASTIN; CENTURION VISION SYSTEM; DUOVISC VISCOELASTIC SYSTEM; EYLEA; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; RESTASIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR