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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Visual Impairment (2138)
Date of Event	08/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced anisometropia, myopia surprise, corneal edema.The iol exchanged for another lens approximately 1 month following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens has been cut in half, typical of insertion and removal from the eye.Light scratches are observed, on the lens.Power and resolution inspection could not be conducted, due to extensive damage.The file indicated, the use of an unspecified cartridge with an unspecified handpiece and unspecified viscoelastic.The root cause for the reported events could not be determined.A malfunction has not been indicated, or information provided, that the lens was the cause of the event.The file indicates, the clinical reason for explant of "anisometropia".The another diopter lens was replaced with a non company lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12579438
• Report Number: 1119421-2021-01890
• Device Sequence Number: 1101244
• Product Code: HQL
• UDI-Device Identifier: 00380650049032
• UDI-Public: 00380650049032
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 02/24/2025
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.360
• Device Lot Number: 15030376
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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: DIB00 32.0 - REPLACEMENT LENS; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; UNKNOWN CARTRIDGE; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE; DIB00 32.0 - REPLACEMENT LENS; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; UNKNOWN CARTRIDGE; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other; Required Intervention