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

Model Number	MA50BM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacist reported that during the intraocular lens implant procedure, iol found to have crack in iol.Additional information has been requested.
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.No other complaints reported in the lot.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.Both haptics were bent in the distal area.The optic had a large portion of optic lens material cut from the lens (not returned), typical of insertion and removal.The optic has multiple cracks near the cut damaged area.Associated products were not provided.It is unknown if qualified associated products were used.The reported lens 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.Follow-up attempt was conducted.Not enough information was provided to determine if a qualified product combination was used.The instruction for use (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.Company recommends using the qualified company iol delivery system or any other company qualified combination.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: 15698756
• Report Number: 1119421-2022-02319
• Device Sequence Number: 6226785
• Product Code: HQL
• UDI-Device Identifier: 00380650698636
• UDI-Public: 00380650698636
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 03/18/2025
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.250
• Device Lot Number: 15058008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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
• Patient Sex: Unknown