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

Model Number	CNW0T6
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that once the intraocular lens (iol) was implanted, a foreign material was observed on the trailing haptic.The iol was removed during surgery because the foreign material could not be removed by irrigation & aspiration.When iol was removed, the trailing haptic was checked, and it (trailing haptic) was clearly attached.The doctor said that the lens seemed to have melted.The surgery was completed after replacing the iol with another one in an initial procedure.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Incomplete device was 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.Photo provided shows one damaged haptic.Iol returned in three pieces wrapped in gauze in a petri dish, the three pieces are adhered to each other.Solution is dried on the iol.One haptic is broken torn and not returned, the other haptic is intact.The optics is cut in three and scratched/marked-rejectable.Evaluation of foreign material and the haptic cannot be performed as neither are returned.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The torn material from the haptic tip may have been interpreted as "foreign material".The lens case base comes into view over the eye, the intraocular lens (iol) haptic tip is damaged.The surgeon removes the iol with tweezers, the iol is inserted into the cartridge and the iol is implanted into the eye.As the iol unfolds, the damaged haptic tip is seen.The video shows the haptic tip to be damaged as the lens is removed from the iol case.The root cause is potentially manufacturing related.If the iol becomes misaligned in the lens case, iol damage may occur.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 16672062
• Report Number: 9612169-2023-00254
• Device Sequence Number: 6445427
• Product Code: MJP
• UDI-Device Identifier: 00380652411127
• UDI-Public: 00380652411127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 03/19/2026
• Device Model Number: CNW0T6
• Device Lot Number: 25381307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown