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

Model Number	SA60AT
Medical Device Problem Codes	Break (1069); 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	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported before intraocular lens (iol) implant procedure, when surgeon attempted to implant company lens, felt that the haptic was stiff and could not be folded properly into a cartridge.The surgeon chose not to continue with the iol implant and wanted the iol replacement.Later it was discovered that the tip of the haptic was already broken with no patient contact.The product was no reprocessed and reused.The procedure was not completed on same day.There was no harm to the patient.Additional information has been requested.
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6., and h.11.The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the distal tip.The broken haptic tip was not returned.The other haptic was broken in the haptic/optic junction and included optic material.The broken portion was not returned.The optic edges were scraped.The posterior optic surface was scraped in the center.The anterior optic surface was scraped near one haptic area.The lens was cleaned with klotho-related protein (klrp) to further evaluate.The one remaining haptic with broken tip was easily pliable using tweezers.The optic was folded using folding tweezers.The optic folded and unfolded with no abnormalities.Product history records were reviewed and documentation indicated the product met release criteria.It is unknown if a company cartridge was used with the lens.The company is only qualified for use in a company cartridge.The viscoelastic information was not provided.It is unknown if a qualified product was used.The reported broken haptic tip damage was observed.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met the 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.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The reported complaint of "haptic was stiff, could not fold properly into a cartridge" could not be confirmed.A pliability assessment of the one remaining haptic (with broken tip damage present) was conducted.This haptic was not stiff when evaluated.The haptic was easily pliable using tweezers.The optic was successfully folded using folding tweezers.The optic folded and unfolded with no abnormalities observed.It is unknown if a qualified cartridge was used with the lens.The instructions for use (ifu) instructs: foldable intraocular lenses are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a 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 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).

• 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: 22112121
• Report Number: 1119421-2025-01539
• Device Sequence Number: 20598631
• Product Code: HQL
• UDI-Device Identifier: 00380652555838
• UDI-Public: (01)00380652555838(17)281027(11)231030(10)15740218
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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.215
• Device Lot Number: 15740218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: UNSPECIFIED CARTRIDGE
• Patient Age: 60 YR
• Patient Sex: Female