MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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 non-healthcare professional reported that during phacoemulsification surgery with iol implantation in the right eye on (b)(6) 2025, the centrally located intracapsular lens was found broken after implantation.The lens was extracted, fragmented into three parts through the 2.4 mm main incision, and a new implant was performed on the same date.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in a.1., a.2.A.3.A., b.5., d.10.Andh.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that surgery was completed with the company lens of same model and diopter.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6 and h.11.The product was not returned for analysis.Only photos and video were returned.The reported complaint was observed on the returned video.Provided photos show company iol carton, company model.The reported event cannot be confirmed from the returned photos.Provided video shows open company lens case (company model) and an implant reply card in the background.A piece of lens (one haptic and a piece of optic) can be observed in the lens case base well; the lens appears to be damaged.The complainant indicates the use of non-company viscoelastic and non-company injector which are not qualified for use with the associated iol model.The incision size indicated did not correlate to the recommended size for the cartridge used.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use(ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Also, the incision size indicated did not correlate to the recommended size for the cartridge used.It is unclear if this may have contributed to the reported event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23655089
• Report Number: 9612169-2025-02358
• Device Sequence Number: 10123940
• Product Code: HQL
• UDI-Device Identifier: 00380655093290
• UDI-Public: (01)00380655093290(17)280128(11)230130(10)25578541
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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.250
• Device Lot Number: 25578541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 01/20/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/23/2025; 02/12/2026
• Date Device Manufactured: 01/30/2023
• 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: CME INJECTOR.; MONARCH III IOL, CARTRIDGE C.; SODIUM HYALURONATE 3%.
• Patient Age: 67 YR
• Patient Sex: Female