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

Model Number	CNWET3
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported during intraocular lens (iol) implantation procedure, when performing the lens injection, the second haptic is broken in half.The lens was retained in eye.Additional information was received stating the physician prescribed non-steroidal anti-inflammatory drug drops to relieve the inflammation.There was a slight dislocation of the iol.They are waiting to see the evolution of close vision to verify the need for an explant.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.The attached photo shows a sheet of paper with handwritten notes from a healthcare professional.The product label is also visible.Additionally, there is, what appears to be a broken haptic attached to the sheet of paper with clear tape.The complainant states the use of non-company intraocular lens (iol) injector and non-company viscoelastic, which are not qualified to be used with the associated product.Based on our observation of the attached photo, a broken haptic is attached to a sheet of paper with a clear tape.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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 VIVITY TORIC EXTENDED VISION 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: 20479067
• Report Number: 9612169-2024-01045
• Device Sequence Number: 20901881
• Product Code: MJP
• UDI-Device Identifier: 00380652466400
• UDI-Public: (01)00380652466400(17)260822(11)220824(10)25478419
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 08/22/2026
• Device Model Number: CNWET3
• Device Catalogue Number: CNWET3.185
• Device Lot Number: 25478419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 08/24/2022
• 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: INFINITI VISION SYSTEM; INTREPID AUTOSERT IOL HANDPIECE; MONARCH III IOL, CARTRIDGE D; OVD- BIOHIALUR AND EYEVISCO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male