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

Model Number	MA60AC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Corneal Edema (1791); Corneal Endothelial Cell Loss (4806)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in the lens case.Upon return, the lens was observed to be placed into the lens case incorrectly resulting in damage.The optic was crushed on top of two posts of the lens case.Blood and solution was dried on the lens.One haptic was pulled from the optic, not returned.The optic was cracked in this haptic insertion area.This may have been interpreted as the reported complaint.It cannot be verified if the haptic was also broken.The second haptic insertion area was torn from the optic with the haptic still attached.This haptic was bent at the haptic insertion area.Complaint and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of an unspecified cartridge.It is unknown if a qualified product was used.The current company model is only qualified for use in the company (a) and (b) cartridges.The file indicated the use of a non-qualified viscoelastic.The handpiece indicated is qualified when used with the qualified lens/cartridge combinations.The reported broken haptic could not be verified.Not enough information was provided to determine if a qualified cartridge was used.The instructions for use (ifu) instructs that a company qualified delivery system and viscoelastic combination should be used.Company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The product investigation could not identify a root cause for the reported "corneal edema, endothelial cell loss" event.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.In addition, the company ifu has specific lens loading instructions for multipiece lenses.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 (diagram provided).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 as shown.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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, it was noted that the lens haptic was broken.The iol was explanted during initial procedure.Additional information has been requested, received and stated there was a rupture of the posterior capsule before iol implantation.It was not possible to implant the lens in the sulcus because the lens was broken.The patient was left aphakic.There was surgical manipulation to remove the iol resulting in 5 days of corneal edema and endothelial cell loss, surgical aphakia, and subsequent iol implantation.The lens was removed in the same session but not replaced.

• 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: 19219691
• Report Number: 1119421-2024-00826
• Device Sequence Number: 8105997
• Product Code: HQL
• UDI-Device Identifier: 00380652552417
• UDI-Public: 00380652552417
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.145
• Device Lot Number: 15153495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC.; MONARCH III INJECTOR.; PROVISC.; UNSPECIFIED CARTRIDGE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown