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	04/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Product device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Four photos were provided.All four images were of the monitor screen displaying the lens inside the eye.The full optic was visible in each photo.A portion of one haptic was visible in all photos.A metal instrument was also visible in 3 of the 4 images, inserted into an incision.This instrument appears to be irrigation and aspiration, as a fluid bubble was observed in each of the images.A deep scrape mark was observed on the optic in all the images near this fluid bubble.The scrape mark appears to be located on the anterior surface along the central optic zone.Due to the location and linear appearance of the scrape mark, the damage is typical in appearance to damage from a handpiece plunger override or damage from a metal instrument used to load the lens.The root cause has not been identified.The manufacturer internal reference number is: 2026-37091.
Event or Problem Description
A non health care professional reported that the patient underwent intraocular lens (iol) implantation surgery.During the procedure, the physician observed a scratch on lens after implanting the iol into the eye.The physician removed the faulty iol and replaced with an another iol.

• Brand Name: ACRYSOF SINGLEPIECE 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: 25150533
• Report Number: 1119421-2026-01035
• Device Sequence Number: 18444857
• Product Code: HQL
• UDI-Device Identifier: 00380652555852
• UDI-Public: (01)00380652555852(17)300906(11)250908(10)16105039
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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.225
• Device Lot Number: 16105039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/21/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 09/08/2025
• 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
• Patient Sex: Unknown