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

Model Number	CNW0T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Corneal Clouding/Hazing (1878); Inflammation (1932); Uveitis (2122)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported following the intraocular lens implantation the patient had experienced endophthalmitis and the lens was explanted.Additional information received stating one-week post operatively the patient had experienced corneal edema, anterior chamber cells and flare, fibrin and vitreous clouding.As a result vitrectomy and anterior chamber washout were performed and the lens was explanted.There were no complications during the surgery.The patient was treated with unspecified steroids, non-steroids and antibiotics post-surgery.The event has resolved.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint lot search report reviewed; there are no other complaints for the reported lot.Deviation lot search report reviewed.There have been no other complaints reported in the lot number.The complainant indicates the use of healon as a viscoelastic, which is not qualified for use with associated iol model.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating the surgeon considers that there was no causal relationship with lens since endophthalmitis did not occur in many other facilities and there is the possibility that there was a problem with the equipment in our hospital.
Additional Manufacturer Narrative
The product was returned for analysis.Iol returned wrapped in gauze bandage along with company p&l label in a clear zip lock bag.Solution is dried on both surfaces of the optic and haptics.Both haptics have fibers - rejectable.The optic is torn/split-cut dividing the iol in two(2) with loose fibers -rejectable.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that according to the surgeon, the lens did not cause the event.Based on this information, the device did not cause/contribute to the event.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: 13385363
• Report Number: 9612169-2022-00029
• Device Sequence Number: 14702111
• Product Code: MJP
• UDI-Device Identifier: 00380652410137
• UDI-Public: 00380652410137
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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: 01/31/2024
• Device Model Number: CNW0T4
• Device Lot Number: 21285331
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 04/05/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/13/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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: BSS PLUS; HEALON; VEGAMOX
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male