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

Model Number	MA60AC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An inventory management specialist reported that during an intraocular lens (iol) implant procedure, the capsular bag was collapsed.Additional information was received stating lens was removed out using cutters and forceps.The surgery was completed on same day with no patient harm.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.The reporter indicated the use of a qualified associated cartridge.The use of an unspecified handpiece was indicated.It is unknown if a qualified handpiece was used.A viscoelastic was indicated which is not qualified for use with the lens/cartridge used.The product investigation could not identify a root cause.Information was provided that in the surgeon's opinion, the product did not cause or contribute to the event.No further information was provided.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: 14744549
• Report Number: 1119421-2022-01316
• Device Sequence Number: 5465214
• Product Code: HQL
• UDI-Device Identifier: 00380652552486
• UDI-Public: 00380652552486
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2025
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.180
• Device Lot Number: 15121312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II CARTRIDGE B; PROVISC; UNSPECIFIED CUTTERS; UNSPECIFIED FORCEPS; UNSPECIFIED INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown