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

Model Number SA60AT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Edema (1791); Macular Edema (1822); Hemorrhage/Bleeding (1888); Uveitis (2122); Muscle Hypotonia (4531)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A literature article entitled, "a randomized controlled trial comparing femtosecond laser¿assisted cataract surgery versus conventional phacoemulsification surgery," listed adverse events that occurred post operatively whereas an intraocular lens (iol) was implanted inside the eye at the time of the event.There was no indications provided that the iol was not associated with the events.The events discussed were corneal edema 6 cases, vitreous prolapse 1 case, macular edema 7 cases, anterior uveitis 2 cases, hypotony 1 case, suprachoroidal hemorrhage 1 case, lens decentration 1 case and lens explanted 1 case.The study involved 400 eyes that were implanted with the iol.The events reported did not distinguish any individual patient information nor event date information.Additional information is not available.

Manufacturer Narrative

The product was not returned for analysis.Complaint history and product history records could not be reviewed because the 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: a randomized controlled trial comparing femtosecond laser¿assisted cataract surgery versus conventional phacoemulsification surgery.The default intraocular lens used for in-the-bag placement was the company lens.Patients were reviewed at 4 weeks postoperatively to perform clinical examination, assess for complications, and gather postoperative data.None of the events were indicated as attributable to the implanted iol.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
• MDR Report Key: 10697523
• MDR Text Key: 211898407
• Report Number: 1119421-2020-01490
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention