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

Model Number	CNWTT5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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.There has been one another complaint reported in the lot number.The complainant indicates the use of non company viscoelastic, which is not qualified for use with company model, this is not a qualified company product combination.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation procedure, the iol itself was in a cracked (shattered) state when it was implanted.The surgery was completed after explanting and replacing the cracked iol by enlarging the incision.Additional information was received stating that there was no potential health impact.The next day, the patient's vision was good.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.The lens and cartridge were returned along with the backing of the lens pouch and fully assembled lens case inside the opened lens carton.The damaged lens and the company cartridge were returned inside folded white gauze material.Blood was dried on the gauze and on the lens.The lens optic was broken.The broken portion of optic contained one full haptic.The remainder of the optic was inside the associated company cartridge at the nozzle area and a portion in the tip.Viscoelastic and blood were observed dried in the cartridge.The cartridge tip has stress lines.The cartridge wings display evidence of handpiece use.The cartridge was cleaned for further evaluation.The lens was removed during cleaning.One haptic was broken in the gusset area and was not returned inside the carton with the remainder of the torn lens.Top coat dye stain testing was conducted with acceptable results.A photo was provided that matched the condition of the returned sample.The returned video shows intraocular lens (iol) implantation.Type of accessories used with iol implantation, such as cartridge and handpiece cannot be confirmed from the video.Serial number of the reported iol is also not visible on the provided video.The preparation of the product is not recorded.The amount of viscoelastic used cannot be confirmed from the video.When the iol is being implanted, the leading haptic appears to be folded onto the optic and appears to be in the correct position for implantation.The plunger appears to underride the iol.When the iol is implanted, broken haptic is observed in the eye.The optic area is broken/torn and an approximately 70% of the optic area is implanted.The remaining optic appears to be stuck in the cartridge and is not implanted.The iol is explanted and a new iol is implanted.Additional information: -the complainant states that: "it had been less than 10 minutes since setting it to the company cartridge".Based on our observation of the provided video, plunger underride was observed.The root cause appears to be related to a failure to follow the instruction for use (ifu).The complainant states that: "it had been less than 10 minutes since setting it to the company cartridge".The company ifu instructs : during lens loading and insertion, do not allow the company toric trifocal 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, the surgeon states the use of a non-qualified viscoelastic.The ifu instructs: "during implantation of the company toric trifocal iol, an company qualified delivery system and ophthalmic ovd combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process".In addition to this, company iol delivery system cartridge ifu instructs: ¿only use an company ovd qualified for use with the company iol delivery system that has been allowed to come to the operating room temperature.Completely fill the cartridge with ovd, as shown in figure 3, immediately prior to loading and delivery of the lens¿.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 PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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: 14603461
• Report Number: 9612169-2022-00253
• Device Sequence Number: 17670611
• Product Code: MJP
• UDI-Device Identifier: 00380652469586
• UDI-Public: 00380652469586
• 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): 08/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2025
• Device Model Number: CNWTT5
• Device Catalogue Number: CNWTT5.195
• Device Lot Number: 25255730
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 CARTRIDGE D; MONARCH III IOL INJECTOR; OPEGAN-HI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown