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

Model Number	MA60AC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during surgery, they noticed that the lens was torn.Procedure was completed on the same day.The issue was noted during insertion.Additional information has been requested and received stating that the back up lens was used to complete the procedure.
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
Additional information has been provided in h.3., h.6., and h.11.The lens was returned wrapped in gauze.Surgical solution was observed on both sides of the lens.One haptic was broken with a portion retained in the haptic insertion area, the broken portion was returned.The second haptic was bent at distal end area.The lens had been cut from the edge across the center of the optic, typical of a removal.Long scratches were observed near the cut area.Forceps marks were observed around the optic edge.This appeared to be removal damage.A batch 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 medical device file were met.Information provided indicated that a company cartridge and handpiece were not used.It is unknown if a non-qualified delivery system was used or if the lens was being implanted manually.The company lens is only qualified for use with the company ii (a) and (b) cartridges.The lens was returned.A broken haptic was observed.This may have been the intended complaint.The optic was not torn.The optic had been cut from the edge toward the center typical of a removal.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Information provided indicated that a monarch cartridge and handpiece were not used.It is unknown if a non-qualified delivery system was used or if the lens was being implanted manually.The company is only qualified for use with the company ii (a) and (b) cartridges.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.The investigation has been completed based on current information.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaints are reviewed and monitored for adverse trends on a monthly basis.No adverse trends have been observed associated with the reported product and event.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action is warranted at this time.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: 25791848
• Report Number: 1119421-2026-01460
• Device Sequence Number: 5852913
• Product Code: HQL
• UDI-Device Identifier: 00380652552622
• UDI-Public: (01)00380652552622(17)261204(11)211206(10)15308871
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2026

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: MA60AC
• Device Catalogue Number: MA60AC.250
• Device Lot Number: 15308871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 12/06/2021
• 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
• Patient Sex: Unknown