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

Model Number SA6AT5

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information was requested and received.(b)(4).

Event Description

A facility representative reported that one month following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens model and power.The reason given was wrong power for the patient.The representative reported there was no enlarged incision or sutures required.

Manufacturer Narrative

Product evaluation: the lens was returned in a piece of surgical gauze.Solution is dried on the lens.The lens was cut in half.The optic has a small split coming from the gusset area.The optic is also split for the optic edge towards the center of the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.The lens was returned cut in half.A power/resolution test could not be performed due to the lens being cut in half.Product history records were reviewed and the documentation indicated the product met release criteria.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8196296
• MDR Text Key: 131402757
• Report Number: 1119421-2018-01795
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

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 Expiration Date: 05/31/2022
• Device Model Number: SA6AT5
• Device Lot Number: 12548163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC PLUS; AMVISC PLUS
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR