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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
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 physician reported that during implantation of intraocular lens (iol), the surgeon noticed the tears/cracks in the iol after implantation and this has two cracks in the periphery.The iol remained in the eye.No complications are expected.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.Returned photo shows implanted iol.There are dark marks/lines visible over the iol optic; one at the optic/haptic junction area and the other one at 2 o'clock position.Observed lines/marks appear to be the reported tears/cracks.Based on our observation of the attached photo, what appears to be the reported "tears/cracks" are observed on the optic.A crack can occur in this section of the iol if the iol is placed incorrectly in the delivery device and/or if the correct dwell time is not adhered to as this can result in stress on the iol as it travels through the delivery device/cartridge resulting in a crack/fracture of the optic.The cartridge ifu instructs: 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.It also instructs that prior to loading the iol, the cartridge must be used at operating room temperature of between 18 degree c and 23 degree c.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The iol ifu instructs: 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.In addition to this, company foldable iols are qualified for use with a company qualified delivery system and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 19559007
• Report Number: 9612169-2024-00566
• Device Sequence Number: 4734782
• Product Code: MJP
• UDI-Device Identifier: 00380652409674
• UDI-Public: (01)00380652409674(17)261023(11)221025(10)25517685(21)25517685084
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 25517685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/13/2024
• Date Device Manufactured: 10/25/2022
• 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 MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 81 YR
• Patient Sex: Male