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

Model Number	MA60AC
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
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 physician reported that during surgery, after implantation they have noticed that the lens was opaque and proceeded to remove it from the patient's eye.Subsequently the lens was removed during initial procedure and completed with another lens with same diopter.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in d.9.,h.3., h.6., and h.11.The lens was returned positioned correctly (posterior surface up) in the lens case inside the lens carton.Viscoelastic was dried on the lens.One haptic was broken in the distal area.The broken haptic was not returned.The optic has a small scratch at the optic edge on the anterior and posterior surfaces.The optic edge was broken (material not returned) and additional area was torn (still attached).The optic was also torn and split from the edge to the optic center.The lens was cleaned with klrp for further evaluation.No additional damage was observed.The appearance of the lens was clear.There was no opaqueness observed after the dried viscoelastic was removed.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified associated products were used.The root cause cannot be determined for the reported complaint of opaque lens.The lens was returned with dried viscoelastic, severe optic damage and broken haptic damage.The lens was cleaned with klrp for further evaluation.The lens appeared clear and did not have any appearance of opaqueness after the removal of the dried viscoelastic.It is unknown if the observed optic damage was interpreted as opaque lens.The instructions for use (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 viscosurgical device (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.The ifu instructs: company foldable intraocular lens (iol) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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.File will be reopened if new information 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: 20695942
• Report Number: 1119421-2024-02232
• Device Sequence Number: 12384393
• Product Code: HQL
• UDI-Device Identifier: 00380652552554
• UDI-Public: (01)00380652552554(17)280918(11)230921(10)15711662
• Combination Product (Y/N): N
• Initial Reporter Country: VE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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.215
• Device Lot Number: 15711662
• 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: 10/20/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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