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

Model Number SA6AT5

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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 similar complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that following an intraocular lens (iol) implant procedure, the patient's vision was blurry.The lens was exchanged during a secondary procedure.Additional information was requested.

Manufacturer Narrative

Product evaluation: two portions of the lens, one portion containing a haptic were returned in a specimen cup.Solution is dried on the lens portions returned.The optic is cut into multiple portions, typical of insertion and removal.A large portion of the lens containing the other haptic is missing and was not returned for evaluation.Power and resolution testing could not be conducted due to the extensive optic damage.Product history record could not be reviewed because the facility did not provide a lot number or any identification traceable to the manufacturing documentation.Associated products were not provided.It is unknown if the qualified products were used.The product investigation could not identify a root cause for the reported complaint.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: 8179968
• MDR Text Key: 130879005
• Report Number: 1119421-2018-01774
• 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
• Report Date: 03/19/2019

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: 06/30/2022
• Device Model Number: SA6AT5
• Device Lot Number: 12552542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention