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

Model Number	CNW0T5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was 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).
Event or Problem Description
A physician reported that during implantation of intraocular lens (iol), a crack was observed at the optical part of the iol after insertion of the iol, so the insertion was stopped and the surgery was completed after replacing the product with another one.There's no patient harm.The physician recognized that there was no problem with the replacement and no health hazard.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The product and video was returned for analysis and the reported complaint was observed.Iol evaluation: iol returned in zip lock bag.Solution is dried on the iol.Both haptics are intact.The optic is cracked/fractured and scratched/marked-rejectable.The used cartridge was returned.Inadequate viscoelastic was observed in the cartridge.The cartridge had evidence of placement into a handpiece.No cartridge damage was observed.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Video review: the cataract removal was shown.The cartridge preparation and lens loading were not shown.Amount of viscoelastic used could not be determined.At 11:21, immediately following the cataract removal, the cartridge tip comes into view and is inserted into the incision.It is unknown how long the lens was in the cartridge before delivery.The lens was visible advanced almost to the parting line.The lens appeared to be folded correctly.There appeared to be difficulty advancing the lens.The plunger was advanced into/over the optic (inside fold).The plunger could be observed advanced over half of the optic.The advancement continued until the lens was delivered into the eye.After the lens was delivered, the optic could be observed to be broken and cracked by the plunger tip.The lens was cut and pulled back through the incision.A second lens and cartridge were brought into view with the lens advanced almost to the parting line.The lens and cartridge preparation were not shown.The lens was advanced into the eye.The plunger was at the trailing optic edge.No lens damage was observed with the second delivery.A plunger override was observed.The root cause may be related to failure to follow the ifu.Inadequate viscoelastic was observed in 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.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 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.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) 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.Top coat dye stain testing for the cartridge was conducted with acceptable results.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: 16685629
• Report Number: 9612169-2023-00265
• Device Sequence Number: 20658562
• Product Code: MJP
• UDI-Device Identifier: 00380652410724
• UDI-Public: 00380652410724
• 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): 06/19/2023

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: 03/18/2025
• Device Model Number: CNW0T5
• Device Lot Number: 25298830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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