MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
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 consumer (who is also a physician) reported that during a cataract surgery, he was implanted with lens in the left eye.He had issues with reading small print letters.He thought that the vision would be corrected to an extent that he would not require glasses except for small print letters, but that was not the case.He was prescribed with bifocals.For certain reasons, the consumer was asked to continue the medication for another month.Additional information has been requested and received stating that he did not regain the vision to the supposed extent post cataract surgery.Poor vision in all the zones.
Event or Problem Description
Additional information received stating that patient himself requested the doctor to implant the lens as per his research, doctor had explained him everything about the lens and its functional near vision, it was also told that he may require the glasses after the surgery.Patient had cataract only in one eye and now after the surgery he was comparing the vision with the non cataract eye and finding it different.Doctor told that the patient had a posterior subcapsular cataract and clearly explained him before the surgery.After the surgery, patient was explained about the yag laser for clear vision and asked him to visit but he did not turn up.Update from the patient states that he was using the prescribed spectacles, but not very comfortable with the vision.
Additional Manufacturer Narrative
Correction information has been provided in b.5.And additional information has been provided in b.7.The manufacturer internal reference number is: (b)(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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 18855479
• Report Number: 9612169-2024-00199
• Device Sequence Number: 8295004
• Product Code: POE
• UDI-Device Identifier: 00380652405294
• UDI-Public: 00380652405294
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2024

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: CNWET0
• Device Catalogue Number: CNWET0.225
• Device Lot Number: 25653643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 05/03/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/03/2024; 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male