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

Model Number	MA60AC
Medical Device Problem Codes	Defective Component (2292); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
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 nurse reported that during intraocular lens implantation surgery, the lens was found tilted and the haptic was bent.Hence the physician was concerned about the stability of the lens in the eye and decided to explant the lens and replace with another lens in the same procedure.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.10.The lens was returned positioned incorrectly in the lens case inside the lens carton.Viscoelastic was dried on the lens.One haptic was bent in the distal area.The optic has light scratches on the anterior and the posterior surfaces between the optic center and the optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and handpiece was used with a non-qualified viscoelastic.The reported bent haptic damage was observed.The root cause for the observed damage may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The ifu instructs: company foldable intraocular lens (iol)s are qualified for use with company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.It is not possible to confirm the reported iol dislocation of the lens while in the eye prior to explant and return.File will be reopened if new information becomes available.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21025313
• Report Number: 1119421-2024-02623
• Device Sequence Number: 8342861
• Product Code: HQL
• UDI-Device Identifier: 00380652552448
• UDI-Public: (01)00380652552448(17)270521(11)220523(10)15412175
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: MA60AC
• Device Catalogue Number: MA60AC.160
• Device Lot Number: 15412175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 59 YR
• Patient Sex: Male