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

Model Number	MN60AC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Corneal Edema (1791); Rupture (2208); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.There was one other complaint for the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that, the leading haptic bent was noticed before implanting the lens in the delivery system and the cataract procedure turned into an unplanned vitrectomy.The final diagnosis was descemet¿s tear with corneal edema, posterior capsular tear with no vitreous loss noted.The patient left aphakic.The symptoms were not resolved at the time of reporting.
Additional Manufacturer Narrative
The lens was returned wrapped in surgical gauzes.Blood and solution was dried on the lens.Both haptics were bent in the distal area.One haptic was pulled from the haptic insertion area (returned).The pulled out haptic has a bulbous area which is indicative that a weld was performed during the manufacturing process.The haptic insertion area of the pulled out haptic is torn/split/cracked.The optic was cut from edge towards center, typical of insertion and removal.The optic edge has small nick/chips with lens material missing (not returned).The file indicated the use of a qualified cartridge, handpiece, and viscoelastic.The reported bent haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.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: 11984635
• Report Number: 1119421-2021-01202
• Device Sequence Number: 3363466
• Product Code: HQL
• UDI-Device Identifier: 00380655095119
• UDI-Public: 00380655095119
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 10/31/2023
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.200
• Device Lot Number: 12665358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR