MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Eye Injury (1845); Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.A photo was provided of a single-piece natural lens being held by forceps.Viscoelastic was observed on the lens.Both sides (edges) of the lens are damaged-scraped.The damaged lens material will have a white appearance.This type of edge damage typically occurs with rapid advancement with inadequate viscoelastic.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported complaint could not be determined.Based on review of the provided photo, the reported "white deposits on edges" was lens damage.Lens edge damage may occur: ¿ if inadequate viscoelastic is placed in the device as this will cause inadequate coverage of the lens fold path which may cause damage as the lens is advanced.¿ due to rapid advancement faster than the instructions for use (ifu) recommend rate.¿ if the plunger is advanced quickly initially and then slower to stay within the recommended target rate.¿ if the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.¿ if the operating room temperature is too low (< 18°c / 64°f) lens folding and advancement are more difficult.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, surgeon observed white deposits all over edges of the lens subsequently the iol was explanted during initial procedure and sent to laboratory for microbiology.Fortunately no growth was found.Additional information has been requested, received and stated the surgery was completed by removing the faulty lens from the eye and replaced it with the same model.Patient suffered some iris trauma as a consequence of explanting the lens and had to use malyugin ring during the lens exchange procedure, also sutures were needed.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• 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: 19358181
• Report Number: 1119421-2024-00980
• Device Sequence Number: 17734370
• Product Code: HQL
• UDI-Device Identifier: 00380652394840
• UDI-Public: 00380652394840
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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 Expiration Date: 05/14/2026
• Device Model Number: AU00T0
• Device Lot Number: 15645390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MALYUGIN RING; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male