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
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the lens was explanted in a secondary procedure.The clinical reason for explant was wrong power.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in a.2., a.3., b.10., d.9., d.10., h.3., h.6.And h.10.The lens was returned in a piece of surgical gauze.Solution and blood were dried on the lens.One haptic was broken in the haptic insertion area (not returned).A small crack was observed on the edge of the optic.Deep scratch marks were also observed.The lens was cleaned with klrp.Power and resolution were verified.The lens met specification for power and resolution for an company (-)1.0 diopter lens.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported "wrong power" appears to be unrelated the lens.The returned lens power and resolution were verified.The returned lens met specification for power and resolution for a company (-)1.0 diopter lens.Clarification for the event was requested.No explanation was provided on the returned ¿explant¿ form.A replacement lens was not indicated.File will be reopened if new information is received.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18542979
• Report Number: 1119421-2024-00123
• Device Sequence Number: 9163947
• Product Code: HQL
• UDI-Device Identifier: 00380650699299
• UDI-Public: 00380650699299
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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 Model Number: MA60MA
• Device Catalogue Number: MA60MAN010
• Device Lot Number: 15546169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC; HEALON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male