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

Model Number	MA60AC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant surgery, the lens was broken.Additional information has been requested.
Additional Manufacturer Narrative
This record is a duplicate of mfg report # 2523835-2021-00041.There will be no further reports sent under the current mfg number.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: 11877148
• Report Number: 1119421-2021-01091
• Device Sequence Number: 1073194
• Product Code: HQL
• UDI-Device Identifier: 00380652552615
• UDI-Public: 00380652552615
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.245
• Device Lot Number: 12560668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1