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

Model Number	MA50BM
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint history and 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).
Event or Problem Description
A pharmacist reported that a patient was hospitalized for explantation of an intraocular lens of the left eye due to lens decentration.It was noted that the "zonule is disinserted in lower part." the iol was removed and replaced with a competitor¿s anterior chamber iol.Additional information received stating the patient was not hospitalized for more than 24 hours.The new implantation completed with competitor¿s lens with no consequences to the patient.The patient current condition was unknown as patient not yet been seen since the explantation.
Event or Problem Description
Additional clarification received, for event "¿zonule is disinserted in lower part¿.The zonule (of zinn) is a ring of fibrous strands forming a little band that connects the ciliary body with the crystalline lens, on upper and lower side of the lens.The event means, that the fibers are no longer attached on the lower part.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in a clear water-like liquid inside a specimen container.The optic was cut into piece, typical of insertion and removal.A dimensional inspection could not be conducted due to the extensive optic damage.Associated products were not provided it is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.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
• MDR Report Key: 12305814
• Report Number: 1119421-2021-01542
• Device Sequence Number: 3901211
• Product Code: HQL
• UDI-Device Identifier: 00380650698513
• UDI-Public: 00380650698513
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2021

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 Expiration Date: 09/30/2025
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.190
• Device Lot Number: 15102853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/11/2021; 09/20/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 08/30/2021; 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTISAN APHAKE DIOPTER 16.5D; ARTISAN APHAKE DIOPTER 16.5D
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR