MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT3
Medical Device Problem Codes	Malposition of Device (2616); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, on the first day the lens appeared adequately centered.At one week, the patient continued to have fairly good vision with the left of 20/30 at distance and j1 at near.Later, she returned to physician complaining of blurry vision on the left eye, her distance acuity had decreased to 20/50 and her reading acuity had decreased to j4 and was subjectively quite blurry.The lens implant showed severe medial decentration and a shift in the axis of astigmatism from 70 degrees to 120 degrees.There was no evidence of vitreous prolapse.The capsular bag appeared intact.She was taken back to surgery for a repositioning of this lens implant.The lens would not center.The physician was able to freely mobilize it within the capsular bag.At that time, after extensive attempts at re-centering the lens, surgery was terminated with the expectation that physician would reassess this clinically and consider lens exchange.The lens further decentered in her first week postoperatively resulting in vision of 20/80 at distance and no useful reading vision at near.Later month, physician removed the multifocal lens implant extremely carefully.Physician brought it into the anterior chamber without any stress whatsoever on the haptics.At this point, physician noted that the implant was defective.There was a 90% tear at the internal edge of the base of one of the haptics which caused the haptic to fall inward toward the optic explaining the reason why there was no support for this lens implant.The lens was not torn during the insertion process.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned.Photo was provided.The clear single-piece lens was shown on a blue surface.The lens had been cut into two pieces across the center of the optic.One haptic was broken in the outer-gusset area (still attached).A determination for the cause of the haptic damage cannot be made from the photo.Qualified associated products were indicated.Based on review of the provided photo, one haptic was damaged (still attached).The photo showed the lens cut into two pieces, typical of a removal.The root cause for the haptic damage could not be determined.It cannot be determined if the haptic damage was present before the re-centering attempt and the subsequent lens removal.It was indicated that the viscoelastic was at room temperature and that "just the right amount" was used.It cannot be determined if an adequate amount of ophthalmic viscosurgical device (ovd) was used per this statement.The instructions for use (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.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens (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 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.Information was provided that there was an attempt to re-center the lens.The lens decentered further the next day.No mention was made of observed iol damage.The lens was replaced with a non-company iol.File will be reopened if the sample or new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated the patient¿s uncorrected near vision is suboptimal.In the surgeon¿s opinion torn haptic was 100 percent responsible for the lens decentration.The lens was exchanged for another company monofocal lens.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17737115
• Report Number: 1119421-2023-01601
• Device Sequence Number: 5889347
• Product Code: MJP
• UDI-Device Identifier: 00380652457347
• UDI-Public: 00380652457347
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.180
• Device Lot Number: 15332701
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: KELMAN FORCEPS.; MONARCH III IOL CARTRIDGE D.; MONARCH III IOL INJECTOR.; VISCOAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female