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

Model Number	SA60AT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 health care professional reported with a description, defective intra ocular lens (iol).Additional information was received; the defect was haptic tilted during iol implantation.In the surgeon opinion the event was caused due to tilting of the haptic in the cartridge.The iol was removed one the same procedure and completed the procedure with a new iol.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.The reporter stated non-company ophthalmic viscosurgical device (ovd), this is not qualified for use.It was stated that in the surgeon opinion, tilting of the haptic in the cartridge caused or contributed to the event.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that according to the surgeon, the product did not cause the event.It is stated in the file that tilting of the haptic in the cartridge caused the event.Most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the intra ocular lens (iol) and potential complications during the implantation process.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 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: 22779994
• Report Number: 9612169-2025-01630
• Device Sequence Number: 15489988
• Product Code: HQL
• UDI-Device Identifier: 00380650141309
• UDI-Public: (01)00380650141309(17)280516(11)230519(10)25648192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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.340
• Device Lot Number: 25648192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 05/19/2023
• 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: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B.; OVD: METHOCEL.; UNSPECIFIED IOL INJECTOR.; UNSPECIFIED REPLACEMENT LENS.
• Patient Age: 58 YR
• Patient Sex: Male