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

Model Number	CNWTT0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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 non-health care professional reported that during implantation haptic of the lens came off.The lens had to be changed; the patient was not injured.Additional information has been received and stated that during surgery, during lens implantation in the anterior chamber noticed that haptic of the lens came off and the intraocular lens (iol) was explanted and exchanged for unspecified lens during initial procedure.The patient condition is satisfactory.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint broken haptic was observed on the returned photo.Photo review: the returned photo shows an intraocular lens (iol) on surgical gauze.It appears that half of the optic is present in the photo.One haptic is broken/torn and is placed next to the optic.The reporter stated that the photo was taken after lens removal.Based on our observation of the attached photo, an explanted iol is placed on a surgical gauze.It appears that half of the optic is present in the photo.One haptic is broken/torn and is placed next to the optic.A final root cause cannot be determined based on available information.In addition to this, all iol are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed broken haptic would not meet our current release criteria.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 TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20890678
• Report Number: 9612169-2024-01277
• Device Sequence Number: 21066340
• Product Code: MFK
• UDI-Device Identifier: 00380652408165
• UDI-Public: (01)00380652408165(17)271203(11)231205(10)25767196
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: CNWTT0
• Device Catalogue Number: CNWTT0.220
• Device Lot Number: 25767196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/14/2025
• Date Device Manufactured: 12/05/2023
• 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: DISCOVISC; MONARCH III CARTRIDGE D
• Patient Age: 34 YR
• Patient Sex: Female