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

Model Number	MA60AC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned on plastic sealed inside a non-company pouch.Solution was dried on the lens.The optic was cut into pieces, typical of damage created to remove a lens from the eye.The lens was cleaned with klrp (klotho-related protein) to further evaluate.One optic portion was cracked beginning at the optic edge.A scrape mark and a small split was also observed in this area along with a light crack in the rounded shape of the tip of an instrument used to grasp the lens.A 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.A qualified cartridge was used with a non-qualified viscoelastic.An unspecified company handpiece was used.Without the specific model of handpiece, it is unknown if a qualified model was used.The root cause for the reported complaint cannot be determined.There was no damage observed to either haptic.The lens was returned cut into pieces with additional optic damage observed near the edge.The completed questionnaire indicated the lens was cut and removed from the eye.The observed additional optic damage may have been created by the use of an instrument used to grasp the lens to remove from the eye.The company 20.5 diopter lens was removed and replaced with a company 19.0 diopter anterior chamber lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the lens found to be dislocated, lens was not broken or twisted.The lens had been cut and removed in a secondary procedure and the incision was not enlarged.Planned vitrectomy was performed.Capsular bag was not intact.There was unspecified patient impact (not mentioned).Additional information has been requested but is not available at the time of this report.

• Brand Name: ACRYSOF MULTIPIECE 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: 24278945
• Report Number: 1119421-2026-00252
• Device Sequence Number: 8289728
• Product Code: HQL
• UDI-Device Identifier: 00380652552530
• UDI-Public: (01)00380652552530(17)271022(11)221024(10)15520066
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.205
• Device Lot Number: 15520066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; DISCOVISC; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male