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

Model Number	MA60AC
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	05/27/2021
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that, following intraocular lens (iol) implant procedure, the lens was explanted due to defective lens and the zonules did not support the lens, an anterior chamber lens was inserted.Additional information was requested.
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the iol was removed.Additional information was provided from the facility that the iol was exchanged during the initial procedure due to the zonules of the patient did not support the lens.A different model iol was implanted.Additional information was requested.
Additional Manufacturer Narrative
Corrected data provided in: b.2.(removed reportable malfunction), b.5 and h.6.(product code updated from 2588 to 2993).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: 12368235
• Report Number: 1119421-2021-01634
• Device Sequence Number: 3939044
• Product Code: HQL
• UDI-Device Identifier: 00380652552394
• UDI-Public: 00380652552394
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 06/16/2025
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.135
• Device Lot Number: 15076414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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: Other