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

Model Number	MA60AC
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that post intraocular lens (iol) implant procedure, the lens was explanted due to displacement of iol.Additional information was received and provided as the patient developed a cataract following a previously performed retinal detachment repair.Cataract surgery was complicated by a posterior capsule breach.Company lens placement was indicated and a 3- piece company lens implanted.Upon insertion, damage to the trailing haptic was identified.It was opted by the surgeon to leave the lens in place as it appeared centered and operating room staff expressed unfamiliarity in loading a 3-piece iol into the inserter (high likelihood of damaging another lens if attempted).Postoperatively, the iol remained centered for four subsequent post operative visits with uncorrected visual acuity in the 20/25-20/30 range.On (b)(6) 2022, patient presented with decreased vision to 20/50 for approximately 1 week duration.Examination revealed an inferiorly displaced iol with the optic rim within the pupil margin.Patient elected to undergo iol exchange.As capsule/zolunar support could not be verified, the company iol was replaced with an anterior chamber lens on 2/3/22.Patient is recovering well with uncorrected 20/50 vision at the last office visit on 3/9/22.There remain two sutures in the corneal incision, as well as 2+ posterior capsule opacification in the visual axis accounting for this vision.Acuity is expected to further improve following removal of remaining sutures and yag capsulotomy of opacified capsule.Doctor said the issues related to improper loading and insertion of these lenses.I do not believe this will be a problem in the future.It is unclear if the haptic damage was responsible for the iol decentration, or simply inadequate iol support in an eye that had undergone multiple surgeries.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.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: 13974805
• Report Number: 1119421-2022-00656
• Device Sequence Number: 4805517
• Product Code: HQL
• UDI-Device Identifier: 00380652552356
• UDI-Public: 00380652552356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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 Expiration Date: 06/28/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.115
• Device Lot Number: 15224514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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