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

Model Number SA60AT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

The product was not returned.Complaint history and product history records could not be reviewed because the literature report did not provide a lot number or any identification traceable to the manufacturing documentation.A malfunction has not been indicated against the product.The file has been opened from a literature report: clinical features and outcomes of congenital cataract surgery with primary intraocular lens implantation in a tunisian cohort.The surgery consisted of phacoaspiration with posterior capsulorhexis and primary implantation.Group 1 comprised children operated at 2 years and of age and group 2 comprised children operated between 2 and 5 years.The manufacturer internal reference number is: (b)(4).

Event Description

A cohort study was published to describe the clinical features of congenital cataract (cc) in a tunisian cohort and to assess the surgical outcomes of primary intraocular lens implantation in two groups based on the age at surgery.This study was a prospective analysis of children under 5 years with cc that were operated between january 2015 and 2020.The surgery consisted of phacoaspiration with posterior capsulorhexis and primary implantation.The medium and long-term complications of uveitis¿glaucoma¿hyphema syndrome.An optimal technique includes adequately sized anterior and posterior capsulorhexis, a meticulous cortical cleanup, an anterior vitrectomy and in-the-bag hydrophobic iol implantation.Hence, it seems inadequate to reject primary implantation because of an avoidable and curable complication.The study concluded that primary implantation seems to be safe and efficient.

Manufacturer Narrative

Regulatory report attachment was updated the manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: 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: 15913767
• MDR Text Key: 304780874
• Report Number: 1119421-2022-02557
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10-0 NYLON; 2.2 MM KERATOME KNIFE; CEFUROXIME; DEXAMETHASONE; DEXAMETHASONE; GENTAMYCIN AND TROPICAMIDE; PARACENTESIS KNIFE; PHENYLEPHRINE 2.5%,; THREE-PIECE IOL; TROPICAMIDE 0.5%; TRYPAN BLUE; ULTRAFLOW BIMANUAL I/A HANDPIECE SET DSP; ULTRASCAN DIGITAL B ACCESSORY, PROBE; UTRATA FORCEPS; VISCOAT
• Patient Outcome(s): Other