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

Model Number	MA60MA
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported via us food and drug administration medsun program that during an intraocular lens (iol) implant procedure, when retrieving the lens to be implanted from the supply room, the packaging for the lens was labeled unclearly.The patient needed a +3 power lens, and the provider inadvertently pulled a -3 power lens.While the team determined that the provider was unclear that there were two "types" of lenses for this brand (+ vs -), the team identified that the packaging itself was printed in a way that would make a provider misread or mistake the lens.The iol was exchanged following the initial implant procedure.Additional information has been requested and received stating that in the surgeon's opinion, the lens itself was not an issue, but the packaging was indistinct between (+) and (-) on human factors basis.The patient required another surgery, and the lens replaced with correct measurements.The patient's issues were resolved.Surgeon's prognosis was good.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The facility inadvertently pulled the incorrect product.The directions for use state to examine the label on the package for model, power, proper configuration, and expiration date.After opening the cardboard storage container, verify lens case information (e.G., model, power, and serial number) is consistent with information on outer package labeling.The carton label has 2 minus designations: the word minus (in all capital letters) and a minus symbol (-) are clearly printed under the model designation.The lens case label has two designations: the word minus (in all capital letters) and a minus symbol (-) are clearly printed under the model designation.The facility reported that there was an initial time out that caught an incorrect clinic measurement (+6).The correct measurement was determined in the operating room (+3).The team presumed the correct lens after the first error was caught.No additional time out was conducted.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; 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: 22873734
• Report Number: 1119421-2025-02310
• Device Sequence Number: 5775862
• Product Code: HQL
• UDI-Device Identifier: 00380650699312
• UDI-Public: (01)00380650699312(17)260727(11)210729(10)15239497
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 07/27/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MAN030
• Device Lot Number: 15239497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 07/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White