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

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during the cataract surgery with intraocular lens (iol) implant procedure, after successful implantation of the lens into the eye, noticed on the screen that the lens had a notch.The surgeon will examine the patient and decide whether or not to remove the lens from the eye.Additional information has been requested.
Additional 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.Two attached photos show the iol implanted in the eye.The optic appears to have what may be a scrape or a scratch on the anterior surface of the lens near the center.We are unable to confirm the damage without evaluation of the physical sample.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received from the surgeon and stated that, since patient is 90 years old and not reporting on visual disturbances, surgeon decided there is no need for explantation of iol.
Additional Manufacturer Narrative
A qualified cartridge was indicated with a non-company handpiece and viscoelastic.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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
• 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: 16093124
• Report Number: 1119421-2023-00029
• Device Sequence Number: 6559514
• Product Code: HQL
• UDI-Device Identifier: 00380652555845
• UDI-Public: 00380652555845
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 15441265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASICO ROYALE INJECTOR; HPMC FORM BVI; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• Patient Sex: Unknown