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

Model Number	SY60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that at the time of intraocular lens (iol) inspection in cartridge, there was a crack in the iol optic.The doctor believed that the crack was created from defective cartridge.There was no patient contact and no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product intraocular lens (iol) was not returned for analysis.Cartridge was returned and was evaluated under additional quality summary (qs).Photos and video were also received and evaluated under cartridge qs.Damage to the iol cannot be confirmed from the provided photos/video.The used company cartridge was returned.Inadequate viscoelastic was observed in the cartridge.A large aneurysm was observed on the top left of the tip.Tip stress was also observed.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.Photos were provided, which matched the returned cartridge.Photo review: photos were provided on a usb.There were multiple duplicated photos.The specific individual photos are evaluated below.Two photos were of the implanted lens.One with an irrigation/aspiration (i/a) tip visible and one without.No area of focus was designated.The photos were identical otherwise.No cracks were observed.A dark circular area was observed, which appeared to be under the lens.Three photos were provided of the cartridge.The first photo was an angled view of the cartridge.There appeared to be an aneurysm on the top left of the tip.The rest of the cartridge was blurred.The second photo was a partial view of nozzle end and tip.No ophthalmic viscosurgical devices (ovd) was visible.The tip appeared to have stress and an aneurysm.The third photo was of part of the nozzle and tip from the bottom.Tip stress was observed.No ovd was visible.There appeared to be an aneurysm on the left side.The provided very short video clip showed part of the nozzle and the cartridge tip.No ovd was observed.Tip appeared slight bent/pinched which differed from the photos.The root cause for the reported lens damage may be related to a failure to follow the instructions for use (ifu).Inadequate viscoelastic was observed in the cartridge.The tip had a large aneurysm and stress.This damage may indicate the lens/plunger were not in acceptable positions for advancement.Topcoat dye stain testing was conducted with acceptable results.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: 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.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately half turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 21689942
• Report Number: 9612169-2025-00472
• Device Sequence Number: 21152709
• Product Code: HQL
• UDI-Device Identifier: 00380652251563
• UDI-Public: (01)00380652251563(17)270301(11)230303(10)25602557
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 25602557
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/23/2025
• Date Device Manufactured: 03/03/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown