MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number SY60WF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Endophthalmitis (1835); Hypopyon (1913); Blurred Vision (2137); Fibrosis (3167); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/21/2023

Event Type  Injury  

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 Description

A nurse reported that after postoperative day 14 of a cataract surgery a 62 years female patient experienced endophthalmitis in right eye with symptoms of sharp pain that started acutely then vision worsened, positive for staphylococcus infection.Patient also presented with conjunctival inflammation <1+, aqueous cell 3+, aqueous fibrin was present, hypopyon after clinical examination.Symptoms were treated with steroids, antibiotics and intravitreal tap injection.Patients symptoms was improving.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.All intra ocular lens are terminally sterilized with 100% ethylene oxide sterilization.Manufacturer uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.Information was provided by the reporter that it was unknown what may have caused the event.The investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time the manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17170820
• MDR Text Key: 317551160
• Report Number: 1119421-2023-01143
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652251525
• UDI-Public: 00380652251525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.220
• Device Lot Number: 15431408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION; BSS STERILE IRRIGATING SOLUTION; CEFTAZADIME; CUSTOM-PAK SURGICAL PROCEDURE PACK; DEXAMETHASONE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; HAND PIECE; PHACO TIP; SURGICAL PRODUCT, UNSPECIFIED; VANCOMYCIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female