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

Model Number	SA60AT
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the haptic/optic junction area (returned).The optic was leaning and pressed against the posts and down into the well area of the lens case.The associated cartridge was not returned for evaluation.All product and batch history records are quality reviewed prior to product release.The file indicated the use of a qualified cartridge and handpiece.The associated viscoelastic was not provided.It is unknown if a qualified viscoelastic was used.The reported complaint of ¿lens would not load properly¿ could not be confirmed.The associated cartridge was not returned for evaluation.The returned lens was damaged.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.It is unknown if the observed lens damage is related to the loading issue.The associated viscoelastic was not provided.It is unknown if qualified products were used.Company foldable intra ocular lens (iol)s are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The instructions for use (ifu) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that, during intraocular lens implantation surgery, the lens was defective/stiff.The haptic was deformed or asymmetric.There was also lens loading difficulties.There was no patient contact.

• 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: 21700815
• Report Number: 1119421-2025-00848
• Device Sequence Number: 7844466
• Product Code: HQL
• UDI-Device Identifier: 00380652555890
• UDI-Public: (01)00380652555890(17)290323(11)240325(10)15827050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/26/2025

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.245
• Device Lot Number: 15827050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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: MONARCH III CARTRIDGE C; MONARCH III INJECTOR
• Patient Sex: Male