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

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported during an intraocular lens (iol) implant procedure, the haptic element was torn off.Additional information received and stating that, one part of the haptic broke off.During surgery, the iol came out of the injector with a detached haptic in the patient's eyeball.There was no patient harm and the surgeon removed the iol and haptics and reimplanted a new iol with a different serial number.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Received photo shows an intraocular lens (iol) held with tweezers, there appears to be solution on the iol.One haptic is twisted and the other haptic is missing.Based on our observation of the attached photo, one haptic is broken/torn.The origin of the observed damage cannot be confirmed based on the returned photo alone and without evaluating the physical product.The product was subject to handling and the reported damage was highlighted post implantation.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 21985478
• Report Number: 9612169-2025-01009
• Device Sequence Number: 12837675
• Product Code: HQL
• UDI-Device Identifier: 00380652251594
• UDI-Public: (01)00380652251594(17)270729(11)230731(10)25693100
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: SY60WF
• Device Lot Number: 25693100
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/28/2025
• Date Device Manufactured: 07/31/2023
• 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.
• Patient Sex: Unknown