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

Model Number	MA60MA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 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 physician reported that, the patient had a refractive surprise following intraocular lens (iol) implantation.The lens was implanted aiming for -2 and patient had a refractive surprise of +7.The lens exchange will be performed.Additional information requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from physician, that the iol was exchanged for another lens, after unspecified days following the initial implant procedure.Explanted lens is likely fine and no issue.

• 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: 12227917
• Report Number: 1119421-2021-01452
• Device Sequence Number: 3509025
• Product Code: HQL
• UDI-Device Identifier: 00380650699312
• UDI-Public: 00380650699312
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 02/07/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MAN030
• Device Lot Number: 15144651
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/20/2021
• 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; Required Intervention