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

Model Number	SA60WF
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implantation procedure, while inserting the iol into the posterior capsule, the trailing haptic came out twisted and broken inside the patient¿s eye.Hence the lens was explanted and replaced with another lens during the same procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9.,d.10.,h.3.,h.6 and h.11.The lens was returned positioned incorrectly in the lens case.A used company cartridge was also returned inside a non-company pouch inside the lens carton.Viscoelastic was dried on the lens.One haptic was broken in the gusset area.Viscoelastic was observed in the tip of the cartridge.The trailing haptic was observed in the cartridge tip, oriented incorrectly (interpreted as twisted).The trailing haptic was broken in the gusset area.The tip of the trailing haptic was at the cartridge tip exit.The cartridge tip has stress lines.The cartridge wings have evidence of being placed into a handpiece.The cartridge was cleaned for further evaluation.The broken haptic was removed during cleaning.¿top coat¿dye stain testing was conducted with acceptable results.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.A qualified cartridge was used with a non-qualified viscoelastic and an unknown handpiece.It is unknown if a qualified handpiece was used.The reported haptic damage was observed.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The handpiece used with this lens or cartridge combination was not provided.The ifu instructs: company foldable intra ocular lens (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.Top coat dye stain testing results were acceptable.The company 23.0 diopter lens was removed and replaced with a company 23.0 diopter lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 22492370
• Report Number: 1119421-2025-01917
• Device Sequence Number: 7904631
• Product Code: HQL
• UDI-Device Identifier: 00380652332729
• UDI-Public: (01)00380652332729(17)291215(11)241217(10)15968905
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 08/13/2025

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: SA60WF
• Device Catalogue Number: SA60WF.230
• Device Lot Number: 15968905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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: ACRYSOF MULTIPIECE IOL; ACTIVE SENTRY HANDPIECE; HEALON GV; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown