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 Problems Corneal Decompensation (1790); Endophthalmitis (1835); Glaucoma (1875); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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: visual outcomes and complications in infantile cataract surgery: a real - world scenario.This was a prospective observational study evaluating infants with cataract undergoing surgery.Per instruction for use (ifu): company intraocular lenses (iol) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.The use in infants/children is off-label use of the product.Literature article : chattannavar g, badakere a, mohamed a, kekunnaya r.Visual outcomes and complications in infantile cataract surgery: a real - world scenario.Bmj open ophthalmology 2022;7:e000744.Doi:10.1136/bmjophth-2021-000744.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported in a journal article that after a cataract extraction with intraocular lens (iol) implant procedure, the surgical wounds were sutured with non-absorbable nylon suture.The 54 implanted infants were examined on the first postoperative day and under general anesthesia, at the beginning of the first week, during which sutures were removed and glasses or contact lenses were prescribed.Visual axis opacification has occurred in 12 of the infants' eyes with implanted iols.Nine infants with visual axis opacification underwent secondary surgery for membranectomy.Secondary glaucoma was discovered in one of the infants' implanted iols.In another one of the implanted iol, an infant eye developed endophthalmitis.The infant with endophthalmitis received intravitreal antibiotics without any delay as treatment for endophthalmitis.In another implanted iol infant eye, corneal decompensation was diagnosed.In one of the infants, the iol was explanted in a secondary procedure.

• 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: 15937435
• MDR Text Key: 305040928
• Report Number: 1119421-2022-02605
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2022

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
• 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
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/07/2022
• 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
• Patient Outcome(s): Required Intervention; Other