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

Model Number	CCW0T5
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Eye Injury (1845); Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported during intraocular lens (iol) implant procedure, the lens initially planned to implant was 13.0 d toric model (t6) lens.After ora measurement, decided to implant a lens with a slightly lower cylinder power of 13.0 d.That's what switched the order to from within the operating room.The circulating nurse went to get it.When nurse came back, carried a company lens 13.0 d.Surgeon was only focused on the spherical power (13.0 d) and the toric model (t5) and completely failed to see that company lens model name.In fact, surgeon was not even aware that a lens of this model was in their consignment.The incision was widened by 0.5 mm using a knife.The intraocular lens was folded inside the eye was removed with lens insertion forceps.The correct lens with cylinder power was then retrieved from the lens implant room and implanted during initial procedure.The procedure was completed on same day without any harm to the patient.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint appears to be related to customer dissatisfaction and not a product defect.Event was related to wrong implant being given to surgeon during the procedure.Instruction for use (ifu) instructs: "examine the label on the unopened package for model, optical power, proper configuration, and expiration date".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: 18967159
• Report Number: 9612169-2024-00248
• Device Sequence Number: 6497944
• Product Code: MJP
• UDI-Device Identifier: 00380652433815
• UDI-Public: 00380652433815
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: 08/10/2026
• Device Model Number: CCW0T5
• Device Catalogue Number: CCW0T5.135
• Device Lot Number: 25469551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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: CLAREON ABSORBING IOL.; LENS INSERTION FORCEPS.; MASTEL DIAMOND KNIFE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female