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	Prolapse (2475); Capsular Bag Tear (2639)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that during a routine surgery to remove a cataract from the patient's right eye, the capsule and the lens were dehisced.To strengthen it, the surgeon inserted a tension ring and then inserted a new lens.However, the haptic broke off of the lens inside the eye and ruptured the capsule resulting in the leaking of vitreous fluid.The surgeon then needed to perform a vitrectomy to remove this fluid and then stitched the incision in the eye closed without a lens inserted.Incident was fully explained to the patient in the treatment room as well as the plan to insert new lens at a later date when the eye has had time to heal.Consultant put a patch and eye shield over the eye.According to the additional information received, the trailing haptic was broken off the lens.The patient had an emergency vitrectomy performed and was sent home in order for eye to heal.Patient was brought back the following week.The surgery was completed the following week.Other relevant history: during a routine surgery to remove a cataract from the patient right eye, the capsule the lens sits in dehisced.
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.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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: 20370984
• Report Number: 1119421-2024-01951
• Device Sequence Number: 15149412
• Product Code: HQL
• UDI-Device Identifier: 00380652552462
• UDI-Public: (01)00380652552462(17)270508(11)220510(10)15403640(21)15403640011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 11/29/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.170
• Device Lot Number: 15403640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/29/2024
• Date Device Manufactured: 05/10/2022
• 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: TENSION RING.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male