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

Model Number	SY60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Video was provided.Video provided shows iol implantation.Type of accessories used with iol implantation such as cartridge and handpiece cannot be confirmed from the video.The preparation of the product is not recorded.The lens position at the pause location cannot be confirmed, but from available footage it appears to be acceptable.Viscoelastic (ovd) line is visible in the cartridge tip, no exact determination on the ovd fill can be made, however it appears that the cartridge may not have been fully filled with ovd as per instructions for use (ifu) instruction.The lens is implanted, trailing haptic is observe to be attached to the optic for a few second, it releases with no issues.There appears to be marks/lines over the optic edge near the trailing haptic ( at around 7 o'clock position).The lens is cut in half and removed.The complainant indicates non company viscoelastic, which is not qualified for use with the associated iol model.The product investigation could not identify the root cause for the reported complaint "crack was found in iol optic".The product and implantation accessories such as cartridge was not returned for evaluation.Video evaluation confirmed mark on the optic edge.The root cause may be related to failure to follow ifu, as the customer states the use of non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the implantation process.The ifu instructs: fill the device until ovd can be observed flowing to the nozzle tip.This will require approximately 0.28 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly and cause damage.Lens damage may occur: due to the use of a non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to underfill, overfill, misfolding, delivery issues and /or damage.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly and cause delivery issues and /or damage.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement and cause delivery issues and / or product damage.Any of the above listed causes alone, or in combination, may create the reported event.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol/device contributed to the event.All product and batch history records are quality reviewed prior to product release.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, during intraocular lens (iol) implant procedure, the optic was found cracked after insertion of iol.The surgery was performed and completed after replacing the product with another lens.Additional information was requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was obtained from the surgeon that, it took about 1 minute on average from setting iol to the cartridge to inserting it.

• 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: 13477582
• Report Number: 9612169-2022-00041
• Device Sequence Number: 20136329
• Product Code: HQL
• UDI-Device Identifier: 00380652251365
• UDI-Public: 00380652251365
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 Expiration Date: 11/30/2023
• Device Model Number: SY60WF
• Device Lot Number: 21280377
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: CLAREONINJECTOR; FORCEPS; MONARCH III IOL CARTRIDGE D; OPELEAD
• Patient Sex: Unknown