MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT015
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the leading haptic was twisted upon itself and after the iol was injected into the capsular bag, the leading haptic remained twisted but to release without manipulation.As the iol was centered into the bag with a gentle nudge of the sinksy hook, it was noted that the entire leading haptic was amputated at its base.Forceps were used to remove the haptic.The iol was slightly decentered due to the missing haptic so the haptic and iol were removed through an enlarged incision using scissors and copious viscoelastic.A backup iol was injected into the capsular bag and an interrupted nylon suture was used to secure the main temporal incision.The procedure was completed with no patient harm.Additional information has been requested.
Event or Problem Description
Additional information received, the lens loaded easily for the scrub tech.The surgeon inserted the lens into the left eye and saw that the edges were crimped at the haptic portion.Upon rotating the lens into position the haptic was found separated from the lens at the optic edge.The lens was cut and all pieces removed from the eye, surgeon reports the patient is stable.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11485002
• Report Number: 1119421-2021-00557
• Device Sequence Number: 14372306
• Product Code: POE
• UDI-Device Identifier: 00380652424660
• UDI-Public: 00380652424660
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 08/13/2025
• Device Model Number: DAT015
• Device Lot Number: 15088872
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/13/2021
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC; MONARCH III IOL CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR