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

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, the lens stuck with plunger, doctor pulled out and caused haptic broken.Explanted the faulty lens and implanted with unspecified backup lens without complication.Additional information has been received and stated lens was explanted from the device not from the eye.
Additional Manufacturer Narrative
Corrected information provided in d.10 additional information was provided in d.9., h.3., h.6.And h.10.The lens was returned wrapped in surgical gauzes.Solution was dried on the lens.One haptic was broken in the gusset area (not returned).Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The reported "lens stuck with plunger" could not be confirmed.The lens was returned in the lens case for evaluation.The reported broken haptic was observed.It cannot be confirmed that the lens/haptic was in a proper position for advancement inside the cartridge.The cartridge was not returned for evaluation.The instruction for use (ifu) instructs: 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 IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21207164
• Report Number: 1119421-2025-00216
• Device Sequence Number: 8080407
• Product Code: HQL
• UDI-Device Identifier: 00380655093269
• UDI-Public: (01)00380655093269(17)280304(11)230307(10)15591423
• 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): 03/06/2025

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: SN60WF
• Device Catalogue Number: SN60WF.235
• Device Lot Number: 15591423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL , INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown