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

Model Number	SN60WF
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported before intraocular lens (iol) implant procedure, the surgeon noticed that the trailing haptic is the one stuck to the anterior surface of the optic.Surgeon had to use 2 instruments and a considerable amount of effort to get the haptic off the optic with no patient contact.Additional information has been requested and received stating there was patient contact, but no patient harm.
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
Additional information was provided in h.3., h.6.And h.11.It was reported that haptic was observed to be stuck to the optic after implantation.The root cause of the reported issue is deemed to be related to manufacturing process change that increased the likelihood of company haptics adhering to the posterior optic surface following delivery with the company device.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in h.6.And h.11.On previous smdr the evaluation result code of c16 and evaluation conclusion code of d03 was submitted.As per updated reinvestigation it should be c20 and d15.The product was not returned for analysis.The root cause for the reported complaint could not be determined.No sample was returned for analysis.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: 21026933
• Report Number: 9612169-2024-01444
• Device Sequence Number: 9107012
• Product Code: HQL
• UDI-Device Identifier: 00380655093252
• UDI-Public: (01)00380655093252(17)280424(11)230427(10)25631950
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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.230
• Device Lot Number: 25631950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/07/2025; 03/20/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/07/2025; 04/17/2025
• Date Device Manufactured: 04/27/2023
• 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: 2 UNSPECIFIED INSTRUMENTS; MONARCH III IOL INJECTOR; PROVISC; UNSPECIFIED CARTRIDGE
• Patient Sex: Unknown