MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MA50BM
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A pharmacist reported that during an intraocular lens (iol) implant procedure, while introducing the implant into the patient's eye, the haptics did not unfold and remained folded in on themselves.This threatened the stability of the implant, so the surgeon removed the implant by cutting it with anterior chamber scissors and enlarged the main incision.Another sulcus implant with 0.5 more diopter was inserted into the sulcus plane, which was intact over more than 340 degrees.The procedure was completed on the same day, but patient impact was unknown.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in b3, and b5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating consequence was prolonged procedure time.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22739992
• Report Number: 1119421-2025-02187
• Device Sequence Number: 20637617
• Product Code: HQL
• UDI-Device Identifier: 00380650698544
• UDI-Public: (01)00380650698544(17)251004(11)201005(10)15102874
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Expiration Date: 10/04/2025
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.205
• Device Lot Number: 15102874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 10/05/2020
• 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: ANTERIOR CHAMBER SCISSORS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown