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

Model Number	CNW0T3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, after folding the lens into the company cartridge and loading it into the injector, cracks were found on both sides of the iol when it was implanted into the patient eye.It took about 30 seconds from setting the iol to implanting it into the eye.There was no crack before the iol was set, it seems that the crack occurred after the iol was set.The surgeon cut and divide the iol in pieces inside the eye and removed it, then implanted an iol of the same type and power into the eye again and the surgery was completed successfully.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6 and h.11.The product was returned for analysis.The reported event was observed.Intra ocular lens (iol) returned positioned incorrectly in the iol case.Substantial amount of solution is dried on the iol.There is a fracture in one haptic, the other haptic is slightly deformed.The optic is torn/split-cut dividing the iol in two.There are three big fractures in the bigger segment of the optic.There is a crack in the optic edge.The optic surface is scratched/marked-rejectable with loose fibers.A product 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.A video was provided.The lens and cartridge preparation were not shown.It is unknown if adequate viscoelastic was used.The lens loading and initial advancement were not shown.The video started with cartridge tip being inserted into the incision.There appeared to be difficulty inserting the tip.As the lens was advanced, the plunger was clearly visible incorrectly positioned inside the optic fold.As the plunger was advanced, it further overrode the optic.This caused difficulty advancing the lens.After the toric lens was delivered, angled cracks were observed on opposite sides of the optic edge, which were caused by the plunger override.Fold lines were also observed, which may indicate the lens was folded for an extended period of time.These types of fold lines may also occur when the operating room (or)room temperature is too cold, or if inadequate viscoelastic was placed in the device.The lens was cut into three pieces and pulled from the eye through the incision.A second lens was implanted.The lens and cartridge preparation were not shown.The lens loading and initial advancement were not shown.The cartage tip comes into view as it is inserted into the incision.A smaller plunger override was observed as the lens was advanced into the eye.No lens damage was observed.Irrigation and aspiration (i/a) was conducted.The toric lens was positioned.The lens appeared to be slightly off-center.The video ended.It is stated in the file: there was no crack before the iol was set, so it seems that the crack occurred after the iol was set.The root cause for the crack damage was related to a plunger override.The root cause for the plunger override may be related to a failure to follow the intra ocular lens (ifu).It is unknown if a qualified viscoelastic and handpiece were used.It is unknown if adequate viscoelastic was used.The ifu instructs: 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.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.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 TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23704037
• Report Number: 9612169-2025-02413
• Device Sequence Number: 10670223
• Product Code: MJP
• UDI-Device Identifier: 00380652402309
• UDI-Public: (01)00380652402309(17)280517(11)240519(10)25853412
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: CNW0T3
• Device Lot Number: 25853412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2024
• 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 DELIVERY SYSTEM, CARTRIDGE D.; UNSPECIFIED INJECTOR.
• Patient Sex: Unknown