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

Model Number	MN60AC
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There were no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reporter that during implantation of an intraocular lens (iol) the trailing haptic was stuck inside the cartridge and was broken.A backup lens was used to complete the procedure on the same day.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens cases.Solution is dried on the lens.One haptic is broken in the haptic insertion area.The broken portion of haptic was returned halfway in hallway out of a qualified company cartridge.The optic is torn/split/cracked and cut, typical of insertion and removal.A large portion of lens material is missing (not returned).The used qualified company cartridge was returned.Viscoelastic is dried in the cartridge.The cartridge has evidence that it was placed into a handpiece.No tip damage observed.The file indicated the use of a qualified company cartridge, with a company handpiece.The viscoelastic indicated is non-qualified for the company lens/cartridge combination indicated.The root cause for the reported complaint appears to be related to failure to follow the ifu.The file indicates the use of a viscoelastic that is not qualified for the company lens/cartridge combination used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Information was provided in d6a, d6b, d7a, d10, h3 and h10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation, indicated the product met release criteria.The customer, indicated the use of qualified associated products.The product investigation could not identify a root cause for the reported complaint.Haptic manufacturing is a validated process with multiple inspections to verify, the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications, before it is allocated for use.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: 11581362
• Report Number: 1119421-2021-00666
• Device Sequence Number: 17354936
• Product Code: HQL
• UDI-Device Identifier: 00380655095157
• UDI-Public: 00380655095157
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.220
• Device Lot Number: 12667418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 03/07/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 04/29/2021; 09/25/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/07/2021; 05/04/2021; 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC; MONARCH II IOL DELIVERY; MONARCH III IOL INJECTOR