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

Model Number	CCW0T3
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
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 nurse reported that during cataract surgery with intraocular lens (iol) implant procedure, the physician noted the lens was implanted that the dots to line up the toric power were not in the right location on the lens.The physician cut out the lens and replaced it.It was reported that per the surgeon opinion the contributory cause was due to manufacturing error.There was no patient harm reported.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was confirmed.Iol received in two pieces in the iol case.Solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.The axis marks are not adjacent to haptic as required.The product did not meet specifications.Axis marking on iol was observed to be not adjacent to haptic as required.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 UV ABSORBING 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: 17389174
• Report Number: 9612169-2023-00560
• Device Sequence Number: 3864033
• Product Code: MJP
• UDI-Device Identifier: 00380652431699
• UDI-Public: 00380652431699
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2026
• Device Model Number: CCW0T3
• Device Catalogue Number: CCW0T3.135
• Device Lot Number: 25469741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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: PROVISC
• Patient Age: 65 YR
• Patient Sex: Female