MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.A small nick is observed on the edge of the anterior surface of one of the haptics.A small scratch and crack is observed on the edge of the anterior surface of the optic.The lens was cleaned with klrp for further evaluation.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.The reported event could not be confirmed.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.Qualified associated products were indicated.The ifu (instructions for use): using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd (ophthalmic viscosurgical device) filled cartridge.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.Company ifu: follow the section regarding directions for use for information on the maximum allowed time for the iol (intraocular lens) to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, with description of defective.Additional information has been received and it states that the lens did not unfold in the eye.Surgery was completed on the on the same day with another unspecified lens without any harm to the patient.In surgeon opinion the patient condition was good and the issue was resolved.Additional information has been requested but is not available at the time of this report.

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24754897
• Report Number: 1119421-2026-00656
• Device Sequence Number: 9138151
• Product Code: HQL
• UDI-Device Identifier: 00380652251440
• UDI-Public: (01)00380652251440(17)280501(11)240503(10)15842928
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: SY60WF
• Device Catalogue Number: SY60WF.180
• Device Lot Number: 15842928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 05/03/2024
• 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 III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC; UNSPECIFIED HOLDING FORCEPS
• Patient Age: 75 YR
• Patient Sex: Male