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

Model Number	SY60WF
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following the intraocular lens (iol) implant procedure, patient had poor vision.There was posterior chamber iol bowed.The lens was exchanged with company same model iol but different diopter value after the initial implant procedure.In the surgeons opinion defective lens caused the event.The patient's issue was resolved.The clinical reason for explant was mechanical breakdown.
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.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The account indicated patient had poor vision.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company, 17.5 diopter lens was replaced with a company, 21.0 diopter lens.Based on the information provided, the event does not appear to be related to the product.Additional information was provided during follow up, that the iol was bowed.No further information has been provided at this time.The instructions for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.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 ifu instructs: 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.Due diligence has been performed in an attempt to obtain further information on this event.The product has not been received to evaluate.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Viscoelastic was dried on the lens.The optic was cut into pieces, typical of an insertion and removal.The optic had splintering cracked damage from the jagged cut.The anterior optic surface was cracked near the edge.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The account indicated the use of qualified associated products.The root cause cannot be determined for the reported complaint of "poor vision, intraocular lens (iol) bowed, explant".The account indicated patient had poor vision.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Information was provided that the company, 17.5 diopter lens was replaced with a company, 21.0 diopter lens.Based on the information provided, the visual event does not appear to be related to the product.The lens was returned cut into pieces, typical of an insertion and removal.The lens had additional lens damage.Each lens was subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company, 17.5 diopter lens was replaced with a company, 21.0 diopter lens.Based on the information provided, the "poor vision" portion of the event does not appear to be related to the product.Additional information was provided during follow up, that the iol was bowed.It is unknown what was meant by "iol bowed".The instructions for use (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 ophthalmic viscosurgical device (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.It is unknown if adequate viscoelastic was placed into the cartridge.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The ifu instructs: 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 manufacturer internal reference number is: 2025-31152.

• 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: 22032608
• Report Number: 1119421-2025-01405
• Device Sequence Number: 9484096
• Product Code: HQL
• UDI-Device Identifier: 00380652251433
• UDI-Public: (01)00380652251433(17)280909(11)240911(10)15919096
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2025

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.175
• Device Lot Number: 15919096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/29/2025; 09/02/2025
• Date Device Manufactured: 09/11/2024
• 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: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male