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

Model Number	SA60WF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
A surgical technologist reported that, following an intraocular lens (iol) implant procedure, the patient had experienced visual disturbance.The iol was exchanged during a secondary procedure.The clinical reason given for the explant was ¿iol displacement¿.Additional information was requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that, the patient was not hospitalized and there was no patient's harm involved.The vision was greatly improved.Patient's issues was resolved.

• 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
• 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: 12829080
• Report Number: 1119421-2021-02169
• Device Sequence Number: 16484281
• Product Code: HQL
• UDI-Device Identifier: 00380652332699
• UDI-Public: 00380652332699
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.215
• Device Lot Number: 15099255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male