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

Model Number	MA60AC
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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
A physician reported that during a cataract extraction with an intraocular lens (iol) implant procedure, one of the apathetics was damaged since it had a fissure.It was implanted, but the doctor feared that this fissure could damage the capsular bag and he made the report for quality control and in case when he checks the patient he notices something abnormal, he will choose to replace the lens.Additional information was received stating there was inflammation and displacement of the lens in the capsular bag, if in a week the lens is not centered in the bag, the doctor will explant it to place another one.It was extracapsular surgery, it was implanted without a cartridge.The lens is remains implanted in the patient's eye.Patient's symptoms were continuing.
Additional Manufacturer Narrative
Information was provided that the lens was implanted without using a cartridge.It is unclear how the haptic became damaged.File will be reopened if new information is received.

• 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: 16808115
• Report Number: 1119421-2023-00768
• Device Sequence Number: 6182142
• Product Code: HQL
• UDI-Device Identifier: 00380652552585
• UDI-Public: 00380652552585
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 04/11/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.230
• Device Lot Number: 15182431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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: DUOVISC
• Patient Sex: Unknown