MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the lens was returned wrapped in white gauze material inside the carton along with the tyvek backing of the blister tray and some of the packaging components.Solution was dried on the lens.One haptic was folded onto the anterior optic surface.The distal haptic tip was adhered to the optic in dried solution.There was no broken haptic damage observed.Both haptics were fully intact to the optic.The lens was cleaned using klrp to further evaluate.The bent haptic released from the optic.Both haptics relaxed into the original positions.No damage was observed to the optic or the haptics.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.A product 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.There was no problem found with the lens.The reported "haptic missing" damage was not observed.Both haptics were fully intact to the optic.One haptic was folded onto the optic.The lens was cleaned with krlp to further evaluate.The haptics relaxed into their original positions.No damage was observed to the haptics or optic.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, during the intraocular lens implantation surgery, the haptic was missing.There was no patient contact.The surgery was completed on the same day.Additional information was received stating that another lens was used to complete the surgery.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• 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: 25137884
• Report Number: 1119421-2026-01028
• Device Sequence Number: 15831823
• Product Code: HQL
• UDI-Device Identifier: 00380652395267
• UDI-Public: (01)00380652395267(17)270731(11)240801(10)15901422
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: ACU0T0
• Device Lot Number: 15901422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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