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

Model Number	MA60AC
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported forceful injection may be related to a failure to follow the ifu (instructions for use).A non-qualified handpiece was indicated.The ifu instructs: company foldable iols 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.Based on the surgical notes the posterior capsular-tear occurred before the lens was implanted.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, sudden, unexpected and forceful ejection of iol from the cartridge ruptured the posterior lens capsule and lodged in the vitreous, requiring another eye doctor surgery to retrieve it.Retrieved lens optic and a haptic on recovery were found to be bent.They were likely mangled by undue pressure from a mismatch or defect in the barrel and the iol.Additional information has been received and stated during removal of natural lens, anterior capsule broke and tear extended around to the posterior capsule bringing vitreous into the anterior chamber.Limited anterior vitrectomy was performed without difficulty.As lens was being inserted, it suddenly jumped out and fell into the vitreous.Patient then sent to retina specialist for vitrectomy and repositioning of iol from retina to sulcus.Pars plana vitrectomy was performed, iol was retrieved from the vitreous and explanted.Another iol was gently placed, wound was sutured to close.Iol was centered nicely.

• 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: 17718625
• Report Number: 1119421-2023-01573
• Device Sequence Number: 7213322
• Product Code: HQL
• UDI-Device Identifier: 00380652552516
• UDI-Public: 00380652552516
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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: 08/16/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.195
• Device Lot Number: 15251671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; DUOVISC; MONARCH II CARTRIDGE B; MONARCH II LOADING FORCEPS; UNFOLDER PLATINUM HANDPIECE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male