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

Model Number	MA60AC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Visual Impairment (2138); Capsular Bag Tear (2639)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that a physician did an intraocular lens (iol) repositioning after the iol implantation procedure.Additional information received reporting that the patient had change in vision, dislocated iol.The patient stated on initial consult that he had a history of being hit in that eye about 2 months prior to cataract surgery with a bungee cord.The patient denied any ocular history, refractive surgery except cataracts.Up on examination it was revealed that the lens was dislocated towards his nose with the haptic in the capsular sulcus temporally and the rest of the lens behind the anterior and posterior capsule in the anterior vitreous cavity." there was a radial tear in the capsule at 5 o clock and his pupil was fixed to 5mm or so with an irregular sphincter function that was quite minimal due to the damage at 3 and 9 o clock to the sphincter.Surgical intervention of intraocular lens repositioning, scleral fixation, pars plana vitrectomy and iris cerclage, right eye were performed and patient discharged on the same day.Surgeon¿s prognosis was excellent.In surgeon¿s opinion, the product did not contribute to the event and the radial tear in the capsule might have caused the event.Reason for the tear was unknown.
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in this lot.The lens was repositioned and remains implanted.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: 11820362
• Report Number: 1119421-2021-01020
• Device Sequence Number: 3723810
• Product Code: HQL
• UDI-Device Identifier: 00380652552271
• UDI-Public: 00380652552271
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 04/30/2023
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.075
• Device Lot Number: 12617973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 07/04/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR