MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implantation procedure, the iol did not seat well; therefore, it was removed.A vitrectomy was done and an anterior chamber iol was implanted.The procedure was completed.The patient did well.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11754016
• Report Number: 1119421-2021-00938
• Device Sequence Number: 4138721
• Product Code: HQL
• UDI-Device Identifier: 00380652332644
• UDI-Public: 00380652332644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 12/07/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.190
• Device Lot Number: 15118850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC; MONARCH IOL INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR