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

Model Number	SN60WF
Medical Device Problem Codes	Inaccurate Delivery (2339); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with the description of when the surgeon was doing a wound assisted insertion of the lens, the intraocular lens was half in and half out of the eye.Additional information has been requested.
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in h.6.And h.11.Additional information was provided in b.5.Correction: on initial mdr the product code of a050301 was an error.It should have been a140504 on the original mdr.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, the surgeon was doing wound assisted insertion of the lens and he must have released pressure as the lens was therefore half in and half out of the eye.

• 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: 21094372
• Report Number: 9612169-2025-00056
• Device Sequence Number: 12927847
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: (01)00380655093160(17)280925(11)230928(10)25726829
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.185
• Device Lot Number: 25726829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 09/28/2023
• 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
• Patient Sex: Unknown