MAUDE Adverse Event Report: ALCON RESEARCH, LLC ACRYSOF IQ IOL; INTRAOCULAR LENS

Model Number	SN60WF
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Other
Event or Problem Description
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• Brand Name: ACRYSOF IQ IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 16983983
• Report Number: MW5117759
• Device Sequence Number: 6286383
• Product Code: HQL
• UDI-Device Identifier: 00380655093252
• UDI-Public: 00380655093252
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial

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
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.230
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown