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

Model Number	SA60AT
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with the description hole in the optical part of the (iol)intraocular lens.The patient had scheduled a follow-up to check whether this will effect on the vision.Additional information has been received that the patient was fine but she was thinking to replace the lens.The central vision was good but her peripheral vision was worse due to damage to the lens.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in d.4.Additional information provided in d.10., h.3., h.6.And h.11.The product was not returned.A photo was provided.A hole was not observed.A mark was observed on the anterior optic surface, near one optic/haptic junction.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was used.A non-qualified handpiece and a non-qualified viscoelastic were used.The root cause was most likely related to a failure to follow the (instructions for use) ifu.A non-qualified handpiece and viscoelastic were used.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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.The lens remains implanted.A photo was provided.While a hole in the optic was not observed, a small mark that appears as damage was observed on the anterior optic surface near one optic/haptic junction.Based on the photo, the position of the small mark does not appear that it would have an impact on peripheral vision.File will be reopened if new information or the sample is received.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: 19828420
• Report Number: 1119421-2024-01405
• Device Sequence Number: 8683771
• Product Code: HQL
• UDI-Device Identifier: 00380652555821
• UDI-Public: (01)00380652555821(17)280304(11)230307(10)15597834(21)15597834062
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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.210
• Device Lot Number: 15597834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/23/2024
• Date Device Manufactured: 03/07/2023
• 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: BVI HPMC HYPROMELLOSE; DUCKWORTH & KENT INJECTOR/HANDPIECE; MONARCH III CARTRIDGE C
• Patient Sex: Unknown