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

Model Number	CNWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Conjunctivitis (1784); Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Red Eye(s) (2038); Blurred Vision (2137); Fibrosis (3167); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/08/2023
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 nurse reported that after postoperative day 14 of cataract surgery with ophthalmic handpiece, intraocular lens, phaco tip, viscoelastic device, consumable , a 68 years old female patient experienced with endophthalmitis in left eye with symptoms of eye pain, blurry vision, floater, conjunctival inflammation was <1+, aqueous cell was 3+, aqueous fibrin was present with hypopyon.Patient was treated with intravitreal tap and antibiotics, corticosteroids medications.Culture results revealed no bacterial growth.Current patient condition was unknown.This is the report of patient 3 of 4.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.There have been no other complaints for this lot.Investigation has been completed based on current information.No further action is warranted at this time.Based on our trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL 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: 17133629
• Report Number: 9612169-2023-00454
• Device Sequence Number: 15064955
• Product Code: MJP
• UDI-Device Identifier: 00380652468251
• UDI-Public: 00380652468251
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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 Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.060
• Device Lot Number: 25537898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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: BSS STERILE IRRIGATING SOLUTION; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC VISCOELASTIC SYSTEM; OMIDRIA; PHACO TIP
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female