MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Tear (2050); Blurred Vision (2137)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A government agency reported that a patient underwent cataract surgery on the right eye.The procedure was performed under regional anesthesia.During sedation, regurgitation occurred, causing coughing.After examination, desaturation, a chest x-ray was requested prior to surgery.The results showed no pulmonary focus.Patient seen again at next day of surgery, postoperative examination was normal.The patient was seen again after one week of the surgery, prior to surgery on the left eye, the surgeon noted that the visual acuity of the patient's right eye was 1/20, and the rest of the clinical examination was normal.The patient was immediately referred to a retinal surgeon for advice.The diagnosis of intra-retinal schisis was then evoked.An angiographic examination was carried out on and found no retinal perfusion anomaly.In view of the lack of improvement in visual acuity, it was decided to carry out a cerebro-orbital mri and hyperbaric oxygen therapy.Patient's current condition is unchanged.
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional 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.There were no issues report with the lens implantation.On day one post-op no issues were observed.On day seven post-op surgeon noted vision decrease.The diagnosis of intra-retinal schisis was then determined.An angiographic examination was carried out on 27-jun-2024, and found no retinal perfusion anomaly.There is no indication that the iol was a factor in the reported event.Information provided by the facility indicated that we found no relationship between the saes and the medical devices used during the procedures.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: 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: 20016681
• Report Number: 1119421-2024-01598
• Device Sequence Number: 8591247
• Product Code: POE
• UDI-Device Identifier: 00380652421089
• UDI-Public: (01)00380652421089(17)270711(11)220713(10)15444824(21)15444824035
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: DFT015
• Device Lot Number: 15444824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/30/2024
• Date Device Manufactured: 07/13/2022
• 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: CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC VISCOELASTIC SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Male