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

Model Number	SY60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/15/2025
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 physician reported that during the intraocular lens implant procedure, when lens was inserted, a scratch was found on the root of its haptic then posterior capsule was damaged.Lens was replaced with non-company lens without any issue.However, when it spread scratches at the root of its optic were found.Then, posterior capsule was damaged.Additional information has been received that damage to the posterior capsule occurred after lens insertion.The root of the haptic appears to be broken.The surgeon mentioned that the edge of the broken haptic may have rubbed against the posterior capsule, which could be the cause of the damage.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned for evaluation.Solution is dried on the lens.One haptic is cracked in the gusset area.A video was provided.The cataract removal took approximately 5:25 minutes.The lens and cartridge preparation were not shown.The lens loading was not shown.The cartridge tip came into view as it was inserted into the incision at 5:29 on the video.The yellow lens was visible in the tip.The lens was rapidly advanced into the eye.Both haptics were tucked.The lens was positioned in the eye with an instrument.Fold lines were observed at the center of the optic.This may indicate the lens was folded for an extended period of time.The lens was positioned with an instrument.Another incision was made at the side of the eye.A metal instrument was inserted.The lens was pulled down by the instrument.At this point the leading haptic was observed broken-gusset area still attached.The original incision was widened.The lens was pulled forcibly out of the eye with forceps.The capsule damage could not be verified.A non-company multi-piece lens was inserted with a non-company delivery device.The trailing haptic was outside of the eye.The haptic was pushed in with a metal instrument.The lens was positioned with two metal instruments.The video ended.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.The file indicates the use of a qualified cartridge and handpiece.The file indicates the use of two different viscoelastic with only one being qualified for the lens and monarch combination.The lens was returned and the reported broken haptic was observed.The capsule damage could not be verified.Based on review of the provided video, the haptic damage may be related to a failure to follow the (instructions for use) ifu.The cataract removal took 5:25 minutes.The lens and cartridge preparation and loading were not shown.The cartridge tip was immediately inserted into the incision at 5:29, which would indicate the lens was loaded earlier.The lens was rapidly advanced into the eye.Fold lines were observed at the center of the optic.This may indicate the lens was folded for an extended period of time.Company lenses should not be folded longer than 3 minutes or damage may occur.It is unknown if the not qualified viscoelastic was used in the cartridge.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Ifu: follow the section regarding directions for use for information on the maximum allowed time for the iol 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 ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-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.The manufacturer internal reference number is: (b)(4).

• 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: 23496905
• Report Number: 1119421-2025-02876
• Device Sequence Number: 8911249
• Product Code: HQL
• UDI-Device Identifier: 00380652251532
• UDI-Public: (01)00380652251532(17)280313(11)240315(10)15820975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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 Catalogue Number: SY60WF.225
• Device Lot Number: 15820975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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 CARTRIDGE D; MONARCH III INJECTOR; OPEGAN-HI; VISCOAT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown