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

Model Number	SY60WF
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
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 government agency reported that during cataract surgery with an intraocular lens (iol) implant procedure, on day one, the patient with an existing condition of senile cataract was implanted with an intraocular lens after the cataract was extracted using phacoemulsification during the operation.The physician checked that the external package of the intraocular lens and the preloaded handle were intact.After opening, sodium hyaluronate gel was injected into the intraocular lens.The intraocular lens was implanted into the capsule through the main incision in the left eye of the patient.Because the intraocular lens loop stabilized the intraocular lens in the capsule, while carefully adjusting the position of the intraocular lens, it was found that one side of the intraocular lens loop was broken at the implant head.The intraocular lens implantation and fixation were checked.The injector and the broken lens loop were slowly removed.Sodium hyaluronate gel was injected into the anterior chamber, the main incision and auxiliary incision were sealed with water, and tobramycin and dexamethasone eye ointment were applied to the conjunctival sac for single-eye coverage.The surgery was completed.After close observation of the position of the artificial lens after surgery, it was found that the lens position was offset and showed large astigmatism.On day six after surgery, another surgery was performed.The original incision needed to be enlarged to remove the implanted artificial lens and replace it with a new one.The rupture of the artificial lens loop in this incident led to a second surgery, which increased the difficulty of the procedure by enlarging the original incision and resulted in one suture at the corneal edge.There was a risk of damaging the posterior capsule of the eye, causing poor vision, refractive errors, etc., due to the wear and tear of intraocular tissues caused by the removal of fractured artificial intraocular lenses, prolonging the recovery time after surgery.

• Brand Name: CLAREON 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: 24871949
• Report Number: 9612169-2026-00847
• Device Sequence Number: 15953068
• Product Code: HQL
• UDI-Device Identifier: 00380652251457
• UDI-Public: (01)00380652251457(17)290211(11)250213(10)25992104
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: SY60WF
• Device Lot Number: 25992104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 02/13/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male