MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MN60AC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.There were no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following the implantation of an intraocular lens (iol) it was misplaced.The lens was explanted in the secondary procedure.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported event.The explanted lens was not returned for an evaluation.Information provided in the file indicated that the company lens with 19.0 diopter was removed and replaced with another company lens with 19.0 diopter.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11464673
• Report Number: 1119421-2021-00528
• Device Sequence Number: 11809592
• Product Code: HQL
• UDI-Device Identifier: 00380655095096
• UDI-Public: 00380655095096
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 10/31/2023
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.190
• Device Lot Number: 12665352
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention