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

Model Number	MA60AC
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported with a description of the failure in the haptics of the lens, which prevented its implantation, since it was not in optimal condition due to this defect.Additional information has been received and stated that intraocular lens contained unusual shape in the haptics.There was a patient contact.Additional information has been received and stated that surgeon decided to schedule a new procedure for iol implantation.There was no damage to the patient.
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
The sample was not returned.The provided photo shows the clear lens outside the lens case on what appears to be the lens case carton.One haptic appears broken in the distal area (broken portion not shown in the photo).The other haptic appears bent in the distal area in two places.Due to the clear nature of the lens model being shown on a white background we cannot confirm if viscoelastic is on the lens or not.It is difficult to make a determination without evaluation of the physical sample.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were used.A noncompany viscoelastic was used.Based on our observation of the attached photo, one haptic was severely bent.The other haptic was broken.The presence of clinical solution on the lens cannot be determined.It is difficult to make a determination of handling without evaluation of the physical sample.The root cause for the reported complaint may be related to a failure to follow the ifu (instruction for use).A non qualified viscoelastic was used.The ifu instructs company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a 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 use holding forceps to 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 it is centered with or slightly past the outline etched into the top of the cartridge.Lenses with a 6.5 mm optic diameter may need to be pre folded for easy entry into the back of the cartridge.Lens may be pre folded by gently applying pressure to the edge of the lens while holding the central optic with forceps.The trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.File will be reopened if new information or the sample is received.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: 20665154
• Report Number: 1119421-2024-02197
• Device Sequence Number: 12887331
• Product Code: HQL
• UDI-Device Identifier: 00380652552455
• UDI-Public: (01)00380652552455(17)271109(11)221111(10)15526832
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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.165
• Device Lot Number: 15526832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/08/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/31/2024
• Date Device Manufactured: 11/11/2022
• 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: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; RAYNER OPHTEIS BIO 1.8(VISCOELASTIC)
• Patient Sex: Female