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

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following a cataract surgery with intraocular lens implant procedure, iol was replaced with another lens due to postoperative refraction error and patient's vision was poor.The surgeon considers that lens was not the cause of the postoperative refraction error, and that it was a close-to-special case of lasik eye with the cornea scraped to 32.0d.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis.The iol returned in a non-company sealed pouch.Solution is dried on the iol.The iol is cut in a half through the centre of the optic.The surgeon considers that the product was not the cause of the reported postoperative refraction error, and that it was a close-to-special case of lasik eye with the cornea scraped to 32.0d.The lens was replaced with the same model 18.5 diopter.The root cause for the reported complaint appears to be a coincidental event that was not related to product.The surgeon considers that the product was not the cause of the reported postoperative refraction error, and that it was a close-to-special case of lasik eye with the cornea scraped to 32.0d.The lens was replaced with the same model company, 18.5 diopter.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 IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 15302882
• Report Number: 9612169-2022-00422
• Device Sequence Number: 5162672
• Product Code: HQL
• UDI-Device Identifier: 00380652251402
• UDI-Public: 00380652251402
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 12/13/2024
• Device Model Number: SY60WF
• Device Lot Number: 25238309
• 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: 07/31/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: INTREPID IOL HANDPIECE.; MONARCH CARTRIDGE D.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown