MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SA6AT5

Device Problems Malposition of Device (2616); Scratched Material (3020)

Patient Problem Failure of Implant (1924)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) exchange procedure, there was a complication with the iol exchange and the replacement iol is now malpositioned.The initial iol was really scarred in as the patient waited so long to proceed with the exchange.Additional information has been requested.

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided indicating that approximately 6 weeks following the initial iol exchange, the malpositioned placement iol was exchanged for a different lens model and power.Planning on doing a prk in a couple of months to take care of the astigmatism.

Manufacturer Narrative

Additional information was provided in b1, b2, b5, d7, h1, h3, h6, and h10.Evaluation summary: the root cause for the dislocated lens was indicated by the health care professional (hcp) to be related to surgical complications.This lens was a replacement lens.Hcp indicated there was scarring due to the length of time waited to explant the original lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11099795
• MDR Text Key: 225724244
• Report Number: 1119421-2020-02051
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SA6AT5
• Device Lot Number: 15061957
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 02/10/2021; 03/03/2021
• Supplement Dates FDA Received: 03/01/2021; 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR