MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: 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 healthcare professional reported that following an intraocular lens (iol) implant procedure, as its ¿hack¿ jagged in the patient field of view.The iol was explanted.Additional information has been requested and received stating that the reason why the lens was removed was 4 mark measured on.Sodium chloride drops was used as a medical intervention.There was no patient injury.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the lens.Iol returned in a draw string bag and in four segments, along with a piece of wet surgical fabric.Two empty lens cases were also returned with company lens.It is unknown which lens case belongs to the returned iol.Solution is dried on the iol.One haptic is bent/deformed, the other haptic is intact.The optic is torn/split-cut dividing the iol in four and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint.The lens was returned damaged in four segments, which is consistent with lens having been explanted.Due to this, we are unable to confirm the original condition of the lens.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18473700
• Report Number: 9612169-2024-00038
• Device Sequence Number: 6885594
• Product Code: HQL
• UDI-Device Identifier: 00380655093313
• UDI-Public: 00380655093313
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.260
• Device Lot Number: 25661207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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: BARRETT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female